Critical Care

ORLANDO – For critically ill, mechanically ventilated patients, a strategy of no sedation resulted in a mortality rate that was not significantly different from a strategy of light sedation with interruption, according to results of a multicenter, randomized trial.

The lack of sedation did significantly improve certain secondary endpoints, including a reduced number of thromboembolic events and preservation of physical function, according to Palle Toft, PhD, DMSc, of Odense (Denmark) University Hospital.

However, the 90-day mortality rate was 42.4% in the no-sedation group versus 37.0% in the sedation group in the NONSEDA study, which was intended to test the hypothesis that mortality would be lower in the no-sedation group.

That 5.4 percentage point difference between arms in NONSEDA was not statistically significant (P = .65) in results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine and concurrently published in the New England Journal of Medicine.

Yet that mortality trend is in the “opposite direction” of an earlier, single-center trial by Dr. Toft and colleagues, noted Claude Guérin, MD, PhD, in a related editorial that also appeared in the journal. In that earlier study, the reported hospital mortality rates were 36% for no sedation and 47% for sedation with daily interruption.

“The results from this trial [NONSEDA] are important because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily,” Dr. Guérin wrote in his editorial.

That said, the earlier, single-center trial was not statistically powered to show between-group differences in mortality, Dr. Toft and coauthors wrote in their journal article.

In his presentation, Dr. Toft emphasized that light sedation with a wake-up trial was “comparable” with no sedation with regard to mortality.

“I think my main message is that we have to individualize patient treatment,” Dr. Toft told attendees at a late-breaking literature session. “Many patients would benefit from nonsedation, and some would benefit by light sedation with a daily wake-up trial. We have to respect patient autonomy, and try to establish a two-way communication with patients in 2020.”

Sandra L. Kane-Gill, PharmD, treasurer of SCCM and assistant professor of pharmacy and therapeutics at the University of Pittsburgh, said that current SCCM guidelines recommend using light sedation in critically ill, mechanically ventilated adults.

“I think we should stay consistent with what the guidelines are saying,” Dr. Kane-Gill said in an interview. “How you do that may vary, but targeting light sedation is consistent with what the evidence is suggesting in those guidelines.”

The depth of sedation between the no-sedation group in the light sedation group in the present study was not as great as the investigators had anticipated, which may explain the lack of statistically significant difference in mortality, according to Dr. Kane-Gill.

According to the report, 38.4% of patients in the no-sedation group received medication for sedation during their ICU stay, while Richmond Agitation and Sedation Scores increased in both groups, indicating a more alert state in both groups.

The multicenter NONSEDA trial included 700 mechanically ventilated ICU patients randomized either to no sedation or to light sedation, such that the patient was arousable, with daily interruption.

Previous studies have shown that daily interruption of sedation reduced mechanical ventilation duration, ICU stay length, and mortality in comparison with no interruption, the investigators noted.

While mortality at 90 days did not differ significantly between the no-sedation and light-sedation approaches, no sedation reduced thromboembolic events, Dr. Toft said at the meeting. The number of thrombolic events within 90 days was 10 (5%) in the sedation group and 1 (0.5%) in the no-sedation group (P less than .05), according to the reported data.

Likewise, several measures of physical function significantly improved in an a prior defined subgroup of 200 patients, he said. Those measures included hand grip at extubation and ICU discharge, as well as scores on the Barthel Index for Activities of Daily Living.

Nonsedation might improve kidney function, based on other reported outcomes of the study, Dr. Toft said. The number of coma- and delirium-free days was 3.0 in the no-sedation group versus 1.0 in the sedation group (P less than .01), he added.

The benefits of no sedation may extend beyond objective changes in health outcomes, according to Dr. Toft. “The patients are able to communicate with the staff, they might be able to enjoy food, in the evening they can look at the television instead of being sedated – and they can be mobilized and they can write their opinion about the treatments to the doctor, and in this way, you have two-way communication,” he explained in his presentation.

Dr. Toft reported that he had no financial relationships to disclose.

SOURCE: Toft P et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1906759.

ORLANDO – For critically ill, mechanically ventilated patients, a strategy of no sedation resulted in a mortality rate that was not significantly different from a strategy of light sedation with interruption, according to results of a multicenter, randomized trial.

The lack of sedation did significantly improve certain secondary endpoints, including a reduced number of thromboembolic events and preservation of physical function, according to Palle Toft, PhD, DMSc, of Odense (Denmark) University Hospital.

However, the 90-day mortality rate was 42.4% in the no-sedation group versus 37.0% in the sedation group in the NONSEDA study, which was intended to test the hypothesis that mortality would be lower in the no-sedation group.

That 5.4 percentage point difference between arms in NONSEDA was not statistically significant (P = .65) in results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine and concurrently published in the New England Journal of Medicine.

Yet that mortality trend is in the “opposite direction” of an earlier, single-center trial by Dr. Toft and colleagues, noted Claude Guérin, MD, PhD, in a related editorial that also appeared in the journal. In that earlier study, the reported hospital mortality rates were 36% for no sedation and 47% for sedation with daily interruption.

“The results from this trial [NONSEDA] are important because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily,” Dr. Guérin wrote in his editorial.

That said, the earlier, single-center trial was not statistically powered to show between-group differences in mortality, Dr. Toft and coauthors wrote in their journal article.

In his presentation, Dr. Toft emphasized that light sedation with a wake-up trial was “comparable” with no sedation with regard to mortality.

“I think my main message is that we have to individualize patient treatment,” Dr. Toft told attendees at a late-breaking literature session. “Many patients would benefit from nonsedation, and some would benefit by light sedation with a daily wake-up trial. We have to respect patient autonomy, and try to establish a two-way communication with patients in 2020.”

Sandra L. Kane-Gill, PharmD, treasurer of SCCM and assistant professor of pharmacy and therapeutics at the University of Pittsburgh, said that current SCCM guidelines recommend using light sedation in critically ill, mechanically ventilated adults.

“I think we should stay consistent with what the guidelines are saying,” Dr. Kane-Gill said in an interview. “How you do that may vary, but targeting light sedation is consistent with what the evidence is suggesting in those guidelines.”

The depth of sedation between the no-sedation group in the light sedation group in the present study was not as great as the investigators had anticipated, which may explain the lack of statistically significant difference in mortality, according to Dr. Kane-Gill.

According to the report, 38.4% of patients in the no-sedation group received medication for sedation during their ICU stay, while Richmond Agitation and Sedation Scores increased in both groups, indicating a more alert state in both groups.

The multicenter NONSEDA trial included 700 mechanically ventilated ICU patients randomized either to no sedation or to light sedation, such that the patient was arousable, with daily interruption.

Previous studies have shown that daily interruption of sedation reduced mechanical ventilation duration, ICU stay length, and mortality in comparison with no interruption, the investigators noted.

While mortality at 90 days did not differ significantly between the no-sedation and light-sedation approaches, no sedation reduced thromboembolic events, Dr. Toft said at the meeting. The number of thrombolic events within 90 days was 10 (5%) in the sedation group and 1 (0.5%) in the no-sedation group (P less than .05), according to the reported data.

Likewise, several measures of physical function significantly improved in an a prior defined subgroup of 200 patients, he said. Those measures included hand grip at extubation and ICU discharge, as well as scores on the Barthel Index for Activities of Daily Living.

Nonsedation might improve kidney function, based on other reported outcomes of the study, Dr. Toft said. The number of coma- and delirium-free days was 3.0 in the no-sedation group versus 1.0 in the sedation group (P less than .01), he added.

The benefits of no sedation may extend beyond objective changes in health outcomes, according to Dr. Toft. “The patients are able to communicate with the staff, they might be able to enjoy food, in the evening they can look at the television instead of being sedated – and they can be mobilized and they can write their opinion about the treatments to the doctor, and in this way, you have two-way communication,” he explained in his presentation.

Dr. Toft reported that he had no financial relationships to disclose.

SOURCE: Toft P et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1906759.

ORLANDO – For critically ill, mechanically ventilated patients, a strategy of no sedation resulted in a mortality rate that was not significantly different from a strategy of light sedation with interruption, according to results of a multicenter, randomized trial.

The lack of sedation did significantly improve certain secondary endpoints, including a reduced number of thromboembolic events and preservation of physical function, according to Palle Toft, PhD, DMSc, of Odense (Denmark) University Hospital.

However, the 90-day mortality rate was 42.4% in the no-sedation group versus 37.0% in the sedation group in the NONSEDA study, which was intended to test the hypothesis that mortality would be lower in the no-sedation group.

That 5.4 percentage point difference between arms in NONSEDA was not statistically significant (P = .65) in results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine and concurrently published in the New England Journal of Medicine.

Yet that mortality trend is in the “opposite direction” of an earlier, single-center trial by Dr. Toft and colleagues, noted Claude Guérin, MD, PhD, in a related editorial that also appeared in the journal. In that earlier study, the reported hospital mortality rates were 36% for no sedation and 47% for sedation with daily interruption.

“The results from this trial [NONSEDA] are important because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily,” Dr. Guérin wrote in his editorial.

That said, the earlier, single-center trial was not statistically powered to show between-group differences in mortality, Dr. Toft and coauthors wrote in their journal article.

In his presentation, Dr. Toft emphasized that light sedation with a wake-up trial was “comparable” with no sedation with regard to mortality.

“I think my main message is that we have to individualize patient treatment,” Dr. Toft told attendees at a late-breaking literature session. “Many patients would benefit from nonsedation, and some would benefit by light sedation with a daily wake-up trial. We have to respect patient autonomy, and try to establish a two-way communication with patients in 2020.”

Sandra L. Kane-Gill, PharmD, treasurer of SCCM and assistant professor of pharmacy and therapeutics at the University of Pittsburgh, said that current SCCM guidelines recommend using light sedation in critically ill, mechanically ventilated adults.

“I think we should stay consistent with what the guidelines are saying,” Dr. Kane-Gill said in an interview. “How you do that may vary, but targeting light sedation is consistent with what the evidence is suggesting in those guidelines.”

The depth of sedation between the no-sedation group in the light sedation group in the present study was not as great as the investigators had anticipated, which may explain the lack of statistically significant difference in mortality, according to Dr. Kane-Gill.

According to the report, 38.4% of patients in the no-sedation group received medication for sedation during their ICU stay, while Richmond Agitation and Sedation Scores increased in both groups, indicating a more alert state in both groups.

The multicenter NONSEDA trial included 700 mechanically ventilated ICU patients randomized either to no sedation or to light sedation, such that the patient was arousable, with daily interruption.

Previous studies have shown that daily interruption of sedation reduced mechanical ventilation duration, ICU stay length, and mortality in comparison with no interruption, the investigators noted.

While mortality at 90 days did not differ significantly between the no-sedation and light-sedation approaches, no sedation reduced thromboembolic events, Dr. Toft said at the meeting. The number of thrombolic events within 90 days was 10 (5%) in the sedation group and 1 (0.5%) in the no-sedation group (P less than .05), according to the reported data.

Likewise, several measures of physical function significantly improved in an a prior defined subgroup of 200 patients, he said. Those measures included hand grip at extubation and ICU discharge, as well as scores on the Barthel Index for Activities of Daily Living.

Nonsedation might improve kidney function, based on other reported outcomes of the study, Dr. Toft said. The number of coma- and delirium-free days was 3.0 in the no-sedation group versus 1.0 in the sedation group (P less than .01), he added.

The benefits of no sedation may extend beyond objective changes in health outcomes, according to Dr. Toft. “The patients are able to communicate with the staff, they might be able to enjoy food, in the evening they can look at the television instead of being sedated – and they can be mobilized and they can write their opinion about the treatments to the doctor, and in this way, you have two-way communication,” he explained in his presentation.

Dr. Toft reported that he had no financial relationships to disclose.

SOURCE: Toft P et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1906759.

This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA  website.) 

An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.

Courtesy NIAID-RML

As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.

On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.

As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.

What are the clinical features of COVID-19?

Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.

Who is at risk for COVID-19?

Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.

Who is at risk for severe disease from COVID-19?

Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.

How is COVID-19 spread?

Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.

When is someone infectious?

Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.

Can someone who has been quarantined for COVID-19 spread the illness to others?

For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.

Can a person test negative and later test positive for COVID-19?

Yes. In the early stages of infection, it is possible the virus will not be detected.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.

What should you do if you suspect a patient for COVID-19?

Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
 

What type of isolation is needed for COVID-19?

Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.

How should health care personnel protect themselves when evaluating a patient who may have COVID-19?

Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).

What face mask do health care workers wear for respiratory protection?

A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.

If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
 

What should you tell the patient if COVID-19 is suspected or confirmed?

Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.

Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?

No.

How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?

At this time, diagnostic testing for COVID-19 can be conducted only at CDC.

The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.

Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?

No.

How is COVID-19 treated?

Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
 

What is considered ‘close contact’ for health care exposures?

Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.

What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?

Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?

None available.

COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?

A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.

What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?

Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
 

What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?

Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).

When can patients with confirmed COVID-19 be discharged from the hospital?

Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.

Considerations to discontinue transmission-based precautions include all of the following:

• Resolution of fever, without the use of antipyretic medication.
• Improvement in illness signs and symptoms.
• Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.

Should people be concerned about pets or other animals and COVID-19?

To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.

Should patients avoid contact with pets or other animals if they are sick with COVID-19?

Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.

Does CDC recommend the use of face masks in the community to prevent COVID-19?

CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.

Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?

No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.

Can people who recover from COVID-19 be infected again?

Unknown. The immune response to COVID-19 is not yet understood.

What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?

The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.

According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.

The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.

Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.

Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.

Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.

This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA  website.) 

An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.

Courtesy NIAID-RML

As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.

On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.

As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.

What are the clinical features of COVID-19?

Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.

Who is at risk for COVID-19?

Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.

Who is at risk for severe disease from COVID-19?

Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.

How is COVID-19 spread?

Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.

When is someone infectious?

Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.

Can someone who has been quarantined for COVID-19 spread the illness to others?

For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.

Can a person test negative and later test positive for COVID-19?

Yes. In the early stages of infection, it is possible the virus will not be detected.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.

What should you do if you suspect a patient for COVID-19?

Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
 

What type of isolation is needed for COVID-19?

Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.

How should health care personnel protect themselves when evaluating a patient who may have COVID-19?

Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).

What face mask do health care workers wear for respiratory protection?

A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.

If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
 

What should you tell the patient if COVID-19 is suspected or confirmed?

Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.

Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?

No.

How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?

At this time, diagnostic testing for COVID-19 can be conducted only at CDC.

The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.

Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?

No.

How is COVID-19 treated?

Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
 

What is considered ‘close contact’ for health care exposures?

Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.

What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?

Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?

None available.

COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?

A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.

What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?

Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
 

What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?

Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).

When can patients with confirmed COVID-19 be discharged from the hospital?

Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.

Considerations to discontinue transmission-based precautions include all of the following:

• Resolution of fever, without the use of antipyretic medication.
• Improvement in illness signs and symptoms.
• Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.

Should people be concerned about pets or other animals and COVID-19?

To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.

Should patients avoid contact with pets or other animals if they are sick with COVID-19?

Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.

Does CDC recommend the use of face masks in the community to prevent COVID-19?

CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.

Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?

No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.

Can people who recover from COVID-19 be infected again?

Unknown. The immune response to COVID-19 is not yet understood.

What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?

The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.

According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.

The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.

Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.

Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.

Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.

This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA  website.) 

An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.

Courtesy NIAID-RML

As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.

On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.

As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.

What are the clinical features of COVID-19?

Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.

Who is at risk for COVID-19?

Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.

Who is at risk for severe disease from COVID-19?

Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.

How is COVID-19 spread?

Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.

When is someone infectious?

Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.

Can someone who has been quarantined for COVID-19 spread the illness to others?

For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.

Can a person test negative and later test positive for COVID-19?

Yes. In the early stages of infection, it is possible the virus will not be detected.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.

What should you do if you suspect a patient for COVID-19?

Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
 

What type of isolation is needed for COVID-19?

Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.

How should health care personnel protect themselves when evaluating a patient who may have COVID-19?

Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).

What face mask do health care workers wear for respiratory protection?

A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.

If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
 

What should you tell the patient if COVID-19 is suspected or confirmed?

Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.

Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?

No.

How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?

At this time, diagnostic testing for COVID-19 can be conducted only at CDC.

The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.

Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?

No.

How is COVID-19 treated?

Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
 

What is considered ‘close contact’ for health care exposures?

Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.

What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?

Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?

None available.

COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?

A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.

What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?

Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
 

What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?

Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).

When can patients with confirmed COVID-19 be discharged from the hospital?

Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.

Considerations to discontinue transmission-based precautions include all of the following:

• Resolution of fever, without the use of antipyretic medication.
• Improvement in illness signs and symptoms.
• Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.

Should people be concerned about pets or other animals and COVID-19?

To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.

Should patients avoid contact with pets or other animals if they are sick with COVID-19?

Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.

Does CDC recommend the use of face masks in the community to prevent COVID-19?

CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.

Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?

No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.

Can people who recover from COVID-19 be infected again?

Unknown. The immune response to COVID-19 is not yet understood.

What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?

The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.

According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.

The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.

Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.

Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.

Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.

ORLANDO – Knowledge of vaping devices, familiarity with terminology, and the ability to quickly pinpoint individuals at risk of lung injury are just a few skills that can help critical care professionals confronted with patients who may have vaping-associated lung disease, according to a new guidance document.

Andrew D. Bowser/MDedge News

The guidance offers a risk-stratification system that classifies patients into groups based on exposure, symptoms, and imaging results, and provides specific evaluation needs and management strategies for each. The guidance is designed to help critical care professionals efficiently identify those at high risk of respiratory failure.

Physicians also need to communicate with patients to identify what substances are being vaped and develop effective methods to encourage abstinence, according to the authors, led by Craig M. Lilly, MD, FCCP, professor of medicine, anesthesiology, and surgery at the University of Massachusetts, Worcester.

“I would encourage every intensivist, when they leave their intensive care unit at night, [to ask], ‘have I advised against vaping today?’ ” Dr. Lilly said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The guidelines, concurrently published as a review article in Critical Care Explorations, propose the term vaping-associated respiratory distress syndrome (VARDS), which the authors say constitutes an acute and progressive respiratory syndrome marked by pathologic changes of lung injury and potentially life-threatening hypoxemic respiratory failure.

They also introduce the three-group Worcester classification system, which is intended to triage vaping-exposed individuals for risk of VARDS based on the presence or absence of vaping-related symptoms and infiltrates, and normal or abnormal oxygen saturation.

“It’s very simple,” said Dr. Lilly, who added that the risk stratification model was developed at the request of Massachusetts public health officials.

Patients with vaping exposure but no symptoms attributable to vaping, such as cough, chest pain, or weight loss, are classified as Worcester Low Risk and testing is not recommended, he said.

By contrast, individuals are considered Worcester Medium Risk if they have vaping exposure, symptoms, and a vaping-associated abnormal pattern on imaging, but no hypoxemia; the presence of hypoxemia would tip the scale toward Worcester High Risk.

“Most patients that have died from vaping have been sent out of emergency rooms when they were noted to be hypoxic,” Dr. Lilly told meeting attendees.

ORLANDO – Knowledge of vaping devices, familiarity with terminology, and the ability to quickly pinpoint individuals at risk of lung injury are just a few skills that can help critical care professionals confronted with patients who may have vaping-associated lung disease, according to a new guidance document.

Andrew D. Bowser/MDedge News

The guidance offers a risk-stratification system that classifies patients into groups based on exposure, symptoms, and imaging results, and provides specific evaluation needs and management strategies for each. The guidance is designed to help critical care professionals efficiently identify those at high risk of respiratory failure.

Physicians also need to communicate with patients to identify what substances are being vaped and develop effective methods to encourage abstinence, according to the authors, led by Craig M. Lilly, MD, FCCP, professor of medicine, anesthesiology, and surgery at the University of Massachusetts, Worcester.

“I would encourage every intensivist, when they leave their intensive care unit at night, [to ask], ‘have I advised against vaping today?’ ” Dr. Lilly said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The guidelines, concurrently published as a review article in Critical Care Explorations, propose the term vaping-associated respiratory distress syndrome (VARDS), which the authors say constitutes an acute and progressive respiratory syndrome marked by pathologic changes of lung injury and potentially life-threatening hypoxemic respiratory failure.

They also introduce the three-group Worcester classification system, which is intended to triage vaping-exposed individuals for risk of VARDS based on the presence or absence of vaping-related symptoms and infiltrates, and normal or abnormal oxygen saturation.

“It’s very simple,” said Dr. Lilly, who added that the risk stratification model was developed at the request of Massachusetts public health officials.

Patients with vaping exposure but no symptoms attributable to vaping, such as cough, chest pain, or weight loss, are classified as Worcester Low Risk and testing is not recommended, he said.

By contrast, individuals are considered Worcester Medium Risk if they have vaping exposure, symptoms, and a vaping-associated abnormal pattern on imaging, but no hypoxemia; the presence of hypoxemia would tip the scale toward Worcester High Risk.

“Most patients that have died from vaping have been sent out of emergency rooms when they were noted to be hypoxic,” Dr. Lilly told meeting attendees.

ORLANDO – Knowledge of vaping devices, familiarity with terminology, and the ability to quickly pinpoint individuals at risk of lung injury are just a few skills that can help critical care professionals confronted with patients who may have vaping-associated lung disease, according to a new guidance document.

Andrew D. Bowser/MDedge News

The guidance offers a risk-stratification system that classifies patients into groups based on exposure, symptoms, and imaging results, and provides specific evaluation needs and management strategies for each. The guidance is designed to help critical care professionals efficiently identify those at high risk of respiratory failure.

Physicians also need to communicate with patients to identify what substances are being vaped and develop effective methods to encourage abstinence, according to the authors, led by Craig M. Lilly, MD, FCCP, professor of medicine, anesthesiology, and surgery at the University of Massachusetts, Worcester.

“I would encourage every intensivist, when they leave their intensive care unit at night, [to ask], ‘have I advised against vaping today?’ ” Dr. Lilly said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The guidelines, concurrently published as a review article in Critical Care Explorations, propose the term vaping-associated respiratory distress syndrome (VARDS), which the authors say constitutes an acute and progressive respiratory syndrome marked by pathologic changes of lung injury and potentially life-threatening hypoxemic respiratory failure.

They also introduce the three-group Worcester classification system, which is intended to triage vaping-exposed individuals for risk of VARDS based on the presence or absence of vaping-related symptoms and infiltrates, and normal or abnormal oxygen saturation.

“It’s very simple,” said Dr. Lilly, who added that the risk stratification model was developed at the request of Massachusetts public health officials.

Patients with vaping exposure but no symptoms attributable to vaping, such as cough, chest pain, or weight loss, are classified as Worcester Low Risk and testing is not recommended, he said.

By contrast, individuals are considered Worcester Medium Risk if they have vaping exposure, symptoms, and a vaping-associated abnormal pattern on imaging, but no hypoxemia; the presence of hypoxemia would tip the scale toward Worcester High Risk.

“Most patients that have died from vaping have been sent out of emergency rooms when they were noted to be hypoxic,” Dr. Lilly told meeting attendees.

ORLANDO – Medicare beneficiaries are receiving a low number of rehabilitation visits in the early posthospitalization period after critical illness, an analysis of hospital and home health claims data suggests.

The beneficiaries, all discharged directly to home health after an intensive care unit stay, received an average of less than one visit per week in the ensuing month, while a full third received no visits at all, according to authors of the analysis, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

Living alone and living in a rural area were associated with significantly fewer home health rehabilitation visits, according to investigator Jason Raymond Falvey, PT, DPT, PhD, of Yale University, New Haven, Conn.

“We identified that these patients are receiving low doses of rehabilitation in home health care settings, and perhaps doses low enough to not be physiologically adequate to overcome the deconditioning and aerobic capacity concerns that these patients have,” Dr. Falvey said.

These findings reflect an “underrecognition” of the importance of rehabilitation both outside and inside the hospital setting, according to Patricia J. Posa, RN, of Saint Joseph Mercy Hospital, Northville, Mich.

“We even struggle to provide sufficient rehabilitation while they’re in the hospital,” Ms. Posa said in an interview. “So I think that we still have a major gap in providing rehab services across the continuum, and part of that is recognizing the deficits that patients, especially our elderly patients, might be leaving the hospital with.”

Medicare beneficiaries who survive a critical illness are often discharged with referrals for physical, occupational, or speech therapy, yet there are not much data on the delivery of that care or how many visits actually take place, according to Dr. Falvey.

SOURCE: Falvey J et al. Crit Care Med. 2020 Jan;48(1):28.

ORLANDO – Medicare beneficiaries are receiving a low number of rehabilitation visits in the early posthospitalization period after critical illness, an analysis of hospital and home health claims data suggests.

The beneficiaries, all discharged directly to home health after an intensive care unit stay, received an average of less than one visit per week in the ensuing month, while a full third received no visits at all, according to authors of the analysis, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

Living alone and living in a rural area were associated with significantly fewer home health rehabilitation visits, according to investigator Jason Raymond Falvey, PT, DPT, PhD, of Yale University, New Haven, Conn.

“We identified that these patients are receiving low doses of rehabilitation in home health care settings, and perhaps doses low enough to not be physiologically adequate to overcome the deconditioning and aerobic capacity concerns that these patients have,” Dr. Falvey said.

These findings reflect an “underrecognition” of the importance of rehabilitation both outside and inside the hospital setting, according to Patricia J. Posa, RN, of Saint Joseph Mercy Hospital, Northville, Mich.

“We even struggle to provide sufficient rehabilitation while they’re in the hospital,” Ms. Posa said in an interview. “So I think that we still have a major gap in providing rehab services across the continuum, and part of that is recognizing the deficits that patients, especially our elderly patients, might be leaving the hospital with.”

Medicare beneficiaries who survive a critical illness are often discharged with referrals for physical, occupational, or speech therapy, yet there are not much data on the delivery of that care or how many visits actually take place, according to Dr. Falvey.

SOURCE: Falvey J et al. Crit Care Med. 2020 Jan;48(1):28.

ORLANDO – Medicare beneficiaries are receiving a low number of rehabilitation visits in the early posthospitalization period after critical illness, an analysis of hospital and home health claims data suggests.

The beneficiaries, all discharged directly to home health after an intensive care unit stay, received an average of less than one visit per week in the ensuing month, while a full third received no visits at all, according to authors of the analysis, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

Living alone and living in a rural area were associated with significantly fewer home health rehabilitation visits, according to investigator Jason Raymond Falvey, PT, DPT, PhD, of Yale University, New Haven, Conn.

“We identified that these patients are receiving low doses of rehabilitation in home health care settings, and perhaps doses low enough to not be physiologically adequate to overcome the deconditioning and aerobic capacity concerns that these patients have,” Dr. Falvey said.

These findings reflect an “underrecognition” of the importance of rehabilitation both outside and inside the hospital setting, according to Patricia J. Posa, RN, of Saint Joseph Mercy Hospital, Northville, Mich.

“We even struggle to provide sufficient rehabilitation while they’re in the hospital,” Ms. Posa said in an interview. “So I think that we still have a major gap in providing rehab services across the continuum, and part of that is recognizing the deficits that patients, especially our elderly patients, might be leaving the hospital with.”

Medicare beneficiaries who survive a critical illness are often discharged with referrals for physical, occupational, or speech therapy, yet there are not much data on the delivery of that care or how many visits actually take place, according to Dr. Falvey.

SOURCE: Falvey J et al. Crit Care Med. 2020 Jan;48(1):28.

ORLANDO – Individuals with opioid use disorder are more likely to be hospitalized for sepsis and die of sepsis, results of a recent retrospective analysis suggest.

Andrew D. Bowser/MDedge News

The prevalence of opioid use disorder (OUD) has significantly increased over the past 15 years, the analysis further shows.

Results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, further suggested that OUD disproportionately contributes to sepsis deaths in younger, healthier patients.

Together, these findings underscore the importance of ongoing efforts to address the opioid epidemic in the United States, according to researcher Mohammad Alrawashdeh, PhD, MSN, a postdoctoral research fellow with Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston.

“In addition to ongoing efforts to combat the opioid crisis, future public health interventions should focus on increasing awareness, recognition, and aggressive treatment of sepsis in this population,” Dr. Alrawashdeh said in an oral presentation of the study.

This study fills an important knowledge gap regarding the connection between OUD and sepsis, according to Greg S. Martin, MD, MS, FCCM, professor of medicine in pulmonary critical care at Emory University, Atlanta, and secretary for the Society of Critical Care Medicine.

“We’ve not really ever been able to piece together the relationship between opioid use disorders and sepsis,” Dr. Martin said in an interview. “It’s not that people wouldn’t suspect that there’s a connection – it’s more that we have simply not been able to get the kind of data that you can use, like they’ve done here, that really helps you to answer that question.”

The study suggests not only that OUD and sepsis are linked, Dr. Martin added, but that health care providers need to be prepared to potentially see further increases in the number of patients with OUD seen in the intensive care unit.

“Both of those are things that we certainly need to be aware of, both from the individual practitioner perspective and also the public health planning perspective,” he said.

SOURCE: Alrawashdeh M et al. Crit Care Med. 2020 Jan;48(1):28. Abstract 56.

ORLANDO – Individuals with opioid use disorder are more likely to be hospitalized for sepsis and die of sepsis, results of a recent retrospective analysis suggest.

Andrew D. Bowser/MDedge News

The prevalence of opioid use disorder (OUD) has significantly increased over the past 15 years, the analysis further shows.

Results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, further suggested that OUD disproportionately contributes to sepsis deaths in younger, healthier patients.

Together, these findings underscore the importance of ongoing efforts to address the opioid epidemic in the United States, according to researcher Mohammad Alrawashdeh, PhD, MSN, a postdoctoral research fellow with Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston.

“In addition to ongoing efforts to combat the opioid crisis, future public health interventions should focus on increasing awareness, recognition, and aggressive treatment of sepsis in this population,” Dr. Alrawashdeh said in an oral presentation of the study.

This study fills an important knowledge gap regarding the connection between OUD and sepsis, according to Greg S. Martin, MD, MS, FCCM, professor of medicine in pulmonary critical care at Emory University, Atlanta, and secretary for the Society of Critical Care Medicine.

“We’ve not really ever been able to piece together the relationship between opioid use disorders and sepsis,” Dr. Martin said in an interview. “It’s not that people wouldn’t suspect that there’s a connection – it’s more that we have simply not been able to get the kind of data that you can use, like they’ve done here, that really helps you to answer that question.”

The study suggests not only that OUD and sepsis are linked, Dr. Martin added, but that health care providers need to be prepared to potentially see further increases in the number of patients with OUD seen in the intensive care unit.

“Both of those are things that we certainly need to be aware of, both from the individual practitioner perspective and also the public health planning perspective,” he said.

SOURCE: Alrawashdeh M et al. Crit Care Med. 2020 Jan;48(1):28. Abstract 56.

ORLANDO – Individuals with opioid use disorder are more likely to be hospitalized for sepsis and die of sepsis, results of a recent retrospective analysis suggest.

Andrew D. Bowser/MDedge News

The prevalence of opioid use disorder (OUD) has significantly increased over the past 15 years, the analysis further shows.

Results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, further suggested that OUD disproportionately contributes to sepsis deaths in younger, healthier patients.

Together, these findings underscore the importance of ongoing efforts to address the opioid epidemic in the United States, according to researcher Mohammad Alrawashdeh, PhD, MSN, a postdoctoral research fellow with Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston.

“In addition to ongoing efforts to combat the opioid crisis, future public health interventions should focus on increasing awareness, recognition, and aggressive treatment of sepsis in this population,” Dr. Alrawashdeh said in an oral presentation of the study.

This study fills an important knowledge gap regarding the connection between OUD and sepsis, according to Greg S. Martin, MD, MS, FCCM, professor of medicine in pulmonary critical care at Emory University, Atlanta, and secretary for the Society of Critical Care Medicine.

“We’ve not really ever been able to piece together the relationship between opioid use disorders and sepsis,” Dr. Martin said in an interview. “It’s not that people wouldn’t suspect that there’s a connection – it’s more that we have simply not been able to get the kind of data that you can use, like they’ve done here, that really helps you to answer that question.”

The study suggests not only that OUD and sepsis are linked, Dr. Martin added, but that health care providers need to be prepared to potentially see further increases in the number of patients with OUD seen in the intensive care unit.

“Both of those are things that we certainly need to be aware of, both from the individual practitioner perspective and also the public health planning perspective,” he said.

SOURCE: Alrawashdeh M et al. Crit Care Med. 2020 Jan;48(1):28. Abstract 56.

ORLANDO – The proportion of children and adolescents admitted to critical care for serious poisonings has increased in recent years, according to authors of a study of more than 750,000 reported opioid exposures.

Fuse/thinkstockphotos.com

Critical care units were involved in 10% of pediatric opioid poisoning cases registered in 2015-2018, up from 7% in 2005-2009, reported Megan E. Land, MD, of Emory University, Atlanta, and coinvestigators.

Attempted suicide has represented an increasingly large proportion of pediatric opioid poisonings from 2005 to 2018, according to the researchers, based on retrospective analysis of cases reported to U.S. poison centers.

Mortality related to these pediatric poisonings increased over time, and among children and adolescents admitted to a pediatric ICU, CPR and naloxone use also increased over time, Dr. Land and associates noted.

These serious consequences of opioid ingestion by children and adolescents emphasize the need for strategies to address suicidality and reduce access to opioids, said Dr. Land, who presented the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

“I think that this really requires a two-pronged approach,” she explained. “One is that we need to increase mental health resources for kids to address adolescent suicidality, and secondly, we need to decrease access to opioids in the hands of pediatric patients by decreasing prescribing and then also getting those that are unused out of the homes.”

Jeffrey Zimmerman, MD, past president of SCCM, said these findings on pediatric opioid poisonings represent the “iceberg tip” of a much larger societal issue that has impacts well beyond critical care.

“I think acutely, we’re well equipped to deal with the situation in terms of interventions,” Dr. Zimmerman said in an interview. “The bigger issue is dealing with what happens afterward, when the patient leaves the ICU in the hospital.”

When the issue is chronic opioid use among adolescents or children, critical care specialists can help by initiating opioid tapering in the hospital setting, rather than allowing the complete weaning process to play out at home, he said.

All clinicians can help prevent future injury by asking questions of the child and family to ensure that any opiates and other prescription medications at home are locked up, he added.

“These aren’t very glamorous things, but they’re common sense, and there’s more need for this common sense now than there ever has been,” Dr. Zimmerman concluded.

The study by Dr. Land and colleagues included data on primary opioid ingestions registered at 55 poison control centers in the United States. They assessed trends over three time periods: 2005-2009, 2010-2014, and 2015-2018.

They found that children under 19 years of age accounted for 28% of the 753,592 opioid poisonings reported over that time period.

The overall number of reported opioid poisonings among children declined somewhat since about 2010. However, the proportion admitted to a critical care unit increased from 7% in the 2005-2009 period to 10% in the 2015-2018 period, said Dr. Land, who added that the probability of a moderate or major effect increased by 0.55% and 0.11% per year, respectively, over the 14 years studied.

Mortality – 0.21% overall – increased from 0.18% in the earliest era to 0.28% in the most recent era, according to the investigators.

Suicidal intent increased from 14% in the earliest era to 21% in the most recent era, and was linked to near tenfold odds of undergoing a pediatric ICU procedure, Dr. Land and colleagues reported.

Among those children admitted to a pediatric ICU, use of CPR increased from 1% to 3% in the earliest and latest time periods, respectively; likewise, naloxone administration increased from 42% to 51% over those two time periods. By contrast, there was no change in use of mechanical ventilation (12%) or vasopressors (3%) over time, they added.

The opioids most commonly linked to pediatric ICU procedures were fentanyl (odds ratio, 12), heroin (OR, 11), and methadone (OR, 15).

Some funding for the study came from the Georgia Poison Center. Dr. Land had no disclosures relevant to the research.

SOURCE: Land M et al. Crit Care Med. 2020 doi: 10.1097/01.ccm.0000618708.38414.ea.

ORLANDO – The proportion of children and adolescents admitted to critical care for serious poisonings has increased in recent years, according to authors of a study of more than 750,000 reported opioid exposures.

Fuse/thinkstockphotos.com

Critical care units were involved in 10% of pediatric opioid poisoning cases registered in 2015-2018, up from 7% in 2005-2009, reported Megan E. Land, MD, of Emory University, Atlanta, and coinvestigators.

Attempted suicide has represented an increasingly large proportion of pediatric opioid poisonings from 2005 to 2018, according to the researchers, based on retrospective analysis of cases reported to U.S. poison centers.

Mortality related to these pediatric poisonings increased over time, and among children and adolescents admitted to a pediatric ICU, CPR and naloxone use also increased over time, Dr. Land and associates noted.

These serious consequences of opioid ingestion by children and adolescents emphasize the need for strategies to address suicidality and reduce access to opioids, said Dr. Land, who presented the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

“I think that this really requires a two-pronged approach,” she explained. “One is that we need to increase mental health resources for kids to address adolescent suicidality, and secondly, we need to decrease access to opioids in the hands of pediatric patients by decreasing prescribing and then also getting those that are unused out of the homes.”

Jeffrey Zimmerman, MD, past president of SCCM, said these findings on pediatric opioid poisonings represent the “iceberg tip” of a much larger societal issue that has impacts well beyond critical care.

“I think acutely, we’re well equipped to deal with the situation in terms of interventions,” Dr. Zimmerman said in an interview. “The bigger issue is dealing with what happens afterward, when the patient leaves the ICU in the hospital.”

When the issue is chronic opioid use among adolescents or children, critical care specialists can help by initiating opioid tapering in the hospital setting, rather than allowing the complete weaning process to play out at home, he said.

All clinicians can help prevent future injury by asking questions of the child and family to ensure that any opiates and other prescription medications at home are locked up, he added.

“These aren’t very glamorous things, but they’re common sense, and there’s more need for this common sense now than there ever has been,” Dr. Zimmerman concluded.

The study by Dr. Land and colleagues included data on primary opioid ingestions registered at 55 poison control centers in the United States. They assessed trends over three time periods: 2005-2009, 2010-2014, and 2015-2018.

They found that children under 19 years of age accounted for 28% of the 753,592 opioid poisonings reported over that time period.

The overall number of reported opioid poisonings among children declined somewhat since about 2010. However, the proportion admitted to a critical care unit increased from 7% in the 2005-2009 period to 10% in the 2015-2018 period, said Dr. Land, who added that the probability of a moderate or major effect increased by 0.55% and 0.11% per year, respectively, over the 14 years studied.

Mortality – 0.21% overall – increased from 0.18% in the earliest era to 0.28% in the most recent era, according to the investigators.

Suicidal intent increased from 14% in the earliest era to 21% in the most recent era, and was linked to near tenfold odds of undergoing a pediatric ICU procedure, Dr. Land and colleagues reported.

Among those children admitted to a pediatric ICU, use of CPR increased from 1% to 3% in the earliest and latest time periods, respectively; likewise, naloxone administration increased from 42% to 51% over those two time periods. By contrast, there was no change in use of mechanical ventilation (12%) or vasopressors (3%) over time, they added.

The opioids most commonly linked to pediatric ICU procedures were fentanyl (odds ratio, 12), heroin (OR, 11), and methadone (OR, 15).

Some funding for the study came from the Georgia Poison Center. Dr. Land had no disclosures relevant to the research.

SOURCE: Land M et al. Crit Care Med. 2020 doi: 10.1097/01.ccm.0000618708.38414.ea.

ORLANDO – The proportion of children and adolescents admitted to critical care for serious poisonings has increased in recent years, according to authors of a study of more than 750,000 reported opioid exposures.

Fuse/thinkstockphotos.com

Critical care units were involved in 10% of pediatric opioid poisoning cases registered in 2015-2018, up from 7% in 2005-2009, reported Megan E. Land, MD, of Emory University, Atlanta, and coinvestigators.

Attempted suicide has represented an increasingly large proportion of pediatric opioid poisonings from 2005 to 2018, according to the researchers, based on retrospective analysis of cases reported to U.S. poison centers.

Mortality related to these pediatric poisonings increased over time, and among children and adolescents admitted to a pediatric ICU, CPR and naloxone use also increased over time, Dr. Land and associates noted.

These serious consequences of opioid ingestion by children and adolescents emphasize the need for strategies to address suicidality and reduce access to opioids, said Dr. Land, who presented the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

“I think that this really requires a two-pronged approach,” she explained. “One is that we need to increase mental health resources for kids to address adolescent suicidality, and secondly, we need to decrease access to opioids in the hands of pediatric patients by decreasing prescribing and then also getting those that are unused out of the homes.”

Jeffrey Zimmerman, MD, past president of SCCM, said these findings on pediatric opioid poisonings represent the “iceberg tip” of a much larger societal issue that has impacts well beyond critical care.

“I think acutely, we’re well equipped to deal with the situation in terms of interventions,” Dr. Zimmerman said in an interview. “The bigger issue is dealing with what happens afterward, when the patient leaves the ICU in the hospital.”

When the issue is chronic opioid use among adolescents or children, critical care specialists can help by initiating opioid tapering in the hospital setting, rather than allowing the complete weaning process to play out at home, he said.

All clinicians can help prevent future injury by asking questions of the child and family to ensure that any opiates and other prescription medications at home are locked up, he added.

“These aren’t very glamorous things, but they’re common sense, and there’s more need for this common sense now than there ever has been,” Dr. Zimmerman concluded.

The study by Dr. Land and colleagues included data on primary opioid ingestions registered at 55 poison control centers in the United States. They assessed trends over three time periods: 2005-2009, 2010-2014, and 2015-2018.

They found that children under 19 years of age accounted for 28% of the 753,592 opioid poisonings reported over that time period.

The overall number of reported opioid poisonings among children declined somewhat since about 2010. However, the proportion admitted to a critical care unit increased from 7% in the 2005-2009 period to 10% in the 2015-2018 period, said Dr. Land, who added that the probability of a moderate or major effect increased by 0.55% and 0.11% per year, respectively, over the 14 years studied.

Mortality – 0.21% overall – increased from 0.18% in the earliest era to 0.28% in the most recent era, according to the investigators.

Suicidal intent increased from 14% in the earliest era to 21% in the most recent era, and was linked to near tenfold odds of undergoing a pediatric ICU procedure, Dr. Land and colleagues reported.

Among those children admitted to a pediatric ICU, use of CPR increased from 1% to 3% in the earliest and latest time periods, respectively; likewise, naloxone administration increased from 42% to 51% over those two time periods. By contrast, there was no change in use of mechanical ventilation (12%) or vasopressors (3%) over time, they added.

The opioids most commonly linked to pediatric ICU procedures were fentanyl (odds ratio, 12), heroin (OR, 11), and methadone (OR, 15).

Some funding for the study came from the Georgia Poison Center. Dr. Land had no disclosures relevant to the research.

SOURCE: Land M et al. Crit Care Med. 2020 doi: 10.1097/01.ccm.0000618708.38414.ea.

ORLANDO – While the impact of the 2019 novel coronavirus outbreak on hospitals outside of China remains to be determined, there are several practical points critical care professionals need to know to be prepared in the face of this dynamic and rapidly evolving outbreak, speakers said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

Andrew Bowser/MDedge News

“Priorities for us in our hospitals are early detection, infection prevention, staff safety, and obviously, taking care of sick people,” said Ryan C. Maves, MD, of the Naval Medical Center San Diego in a special session on the 2019 Novel Coronavirus outbreak.*

Approximately 72,000 cases of coronavirus disease 2019 (COVID-19) had been reported as of Feb. 17, 2020, the day of Dr. Maves’ talk, according to statistics from Johns Hopkins Center for Science and Engineering in Baltimore. A total of 1,775 deaths had been recorded, nearly all of which were in Hubei Province, the central point of the outbreak. In the United States, the number of cases stood at 15, with no deaths reported.

While the dynamics of the 2019 novel coronavirus are still being learned, the estimated range of spread for droplet transmission is 2 meters, according to Dr. Maves. The duration of environmental persistence is not yet known, but he said that other coronaviruses persist in low-humidity conditions for up to 4 days.

The number of secondary cases that arise from a primary infection, or R0, is estimated to be between 1.5 and 3, though it can change as exposure evolves; by comparison, the R0 for H1N1 influenza has been reported as 1.5, while measles is 12-18, indicating that it is “very contagious,” said Dr. Maves. Severe acute respiratory syndrome had an initial R0 of about 3.5, which he said declined rapidly to 0.7 as environmental and policy controls were put into place.

Critical care professionals need to know how to identify patients at risk of having COVID-19 and determine whether they need further work-up, according to Dr. Maves, who highlighted recent criteria released by the Centers for Disease Control and Prevention.

The highest-risk category, he said, are individuals exposed to a laboratory-confirmed coronavirus case, which along with fever or signs and symptoms of a lower respiratory illness would be sufficient to classify them as a “person of interest” requiring further evaluation for disease. A history of travel from Hubei Province plus fever and signs/symptoms of lower respiratory illness would also meet criteria for evaluation, according to the CDC, while travel to mainland China would also meet the threshold, if those symptoms required hospitalization.

The CDC also published a step-wise flowchart to evaluate patients who may have been exposed to the 2019 novel coronavirus. According to that flowchart, if an individual has traveled to China or had close contact with someone infected with the 2019 Novel Coronavirus within 14 days of symptoms, and that individual has fever or symptoms of lower respiratory illness such as cough or shortness of breath, then providers should isolate that individual and assess clinical status, in addition to contacting the local health department.

Andrew Bowser/MDedge News

Laura E. Evans, MD, MS, FCCM, of New York University, said she might recommend providers “flip the script” on that CDC algorithm when it comes to identifying patients who may have been exposed.

“I think perhaps what we should be doing at sites of entry is not talking about travel as the first question, but rather fever or symptoms of lower respiratory illnesses as the first question, and use that as the opportunity to implement risk mitigation at that stage,” Dr. Evans said in a presentation on preparing for COVID-19.

Even with “substantial uncertainty” about the potential impact of the 2019 Novel Coronavirus, a significant influx of seriously ill patients would put strain the U.S. health care delivery system, she added.

“None of us have tons of extra capacity in our emergency departments, inpatient units, or ICUs, and I think we need to be prepared for that,” she added. “We need to know what our process is for ‘identify, isolate, and inform,’ and we need to be testing that now.”

Dr. Maves and Dr. Evans both reported that they had no financial conflicts of interest to report. Dr. Maves indicated that the views expressed in his presentation did not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States government.

*Correction, 2/19/20: An earlier version of this article misstated the location of the naval center.

ORLANDO – While the impact of the 2019 novel coronavirus outbreak on hospitals outside of China remains to be determined, there are several practical points critical care professionals need to know to be prepared in the face of this dynamic and rapidly evolving outbreak, speakers said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

Andrew Bowser/MDedge News

“Priorities for us in our hospitals are early detection, infection prevention, staff safety, and obviously, taking care of sick people,” said Ryan C. Maves, MD, of the Naval Medical Center San Diego in a special session on the 2019 Novel Coronavirus outbreak.*

Approximately 72,000 cases of coronavirus disease 2019 (COVID-19) had been reported as of Feb. 17, 2020, the day of Dr. Maves’ talk, according to statistics from Johns Hopkins Center for Science and Engineering in Baltimore. A total of 1,775 deaths had been recorded, nearly all of which were in Hubei Province, the central point of the outbreak. In the United States, the number of cases stood at 15, with no deaths reported.

While the dynamics of the 2019 novel coronavirus are still being learned, the estimated range of spread for droplet transmission is 2 meters, according to Dr. Maves. The duration of environmental persistence is not yet known, but he said that other coronaviruses persist in low-humidity conditions for up to 4 days.

The number of secondary cases that arise from a primary infection, or R0, is estimated to be between 1.5 and 3, though it can change as exposure evolves; by comparison, the R0 for H1N1 influenza has been reported as 1.5, while measles is 12-18, indicating that it is “very contagious,” said Dr. Maves. Severe acute respiratory syndrome had an initial R0 of about 3.5, which he said declined rapidly to 0.7 as environmental and policy controls were put into place.

Critical care professionals need to know how to identify patients at risk of having COVID-19 and determine whether they need further work-up, according to Dr. Maves, who highlighted recent criteria released by the Centers for Disease Control and Prevention.

The highest-risk category, he said, are individuals exposed to a laboratory-confirmed coronavirus case, which along with fever or signs and symptoms of a lower respiratory illness would be sufficient to classify them as a “person of interest” requiring further evaluation for disease. A history of travel from Hubei Province plus fever and signs/symptoms of lower respiratory illness would also meet criteria for evaluation, according to the CDC, while travel to mainland China would also meet the threshold, if those symptoms required hospitalization.

The CDC also published a step-wise flowchart to evaluate patients who may have been exposed to the 2019 novel coronavirus. According to that flowchart, if an individual has traveled to China or had close contact with someone infected with the 2019 Novel Coronavirus within 14 days of symptoms, and that individual has fever or symptoms of lower respiratory illness such as cough or shortness of breath, then providers should isolate that individual and assess clinical status, in addition to contacting the local health department.

Andrew Bowser/MDedge News

Laura E. Evans, MD, MS, FCCM, of New York University, said she might recommend providers “flip the script” on that CDC algorithm when it comes to identifying patients who may have been exposed.

“I think perhaps what we should be doing at sites of entry is not talking about travel as the first question, but rather fever or symptoms of lower respiratory illnesses as the first question, and use that as the opportunity to implement risk mitigation at that stage,” Dr. Evans said in a presentation on preparing for COVID-19.

Even with “substantial uncertainty” about the potential impact of the 2019 Novel Coronavirus, a significant influx of seriously ill patients would put strain the U.S. health care delivery system, she added.

“None of us have tons of extra capacity in our emergency departments, inpatient units, or ICUs, and I think we need to be prepared for that,” she added. “We need to know what our process is for ‘identify, isolate, and inform,’ and we need to be testing that now.”

Dr. Maves and Dr. Evans both reported that they had no financial conflicts of interest to report. Dr. Maves indicated that the views expressed in his presentation did not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States government.

*Correction, 2/19/20: An earlier version of this article misstated the location of the naval center.

ORLANDO – While the impact of the 2019 novel coronavirus outbreak on hospitals outside of China remains to be determined, there are several practical points critical care professionals need to know to be prepared in the face of this dynamic and rapidly evolving outbreak, speakers said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

Andrew Bowser/MDedge News

“Priorities for us in our hospitals are early detection, infection prevention, staff safety, and obviously, taking care of sick people,” said Ryan C. Maves, MD, of the Naval Medical Center San Diego in a special session on the 2019 Novel Coronavirus outbreak.*

Approximately 72,000 cases of coronavirus disease 2019 (COVID-19) had been reported as of Feb. 17, 2020, the day of Dr. Maves’ talk, according to statistics from Johns Hopkins Center for Science and Engineering in Baltimore. A total of 1,775 deaths had been recorded, nearly all of which were in Hubei Province, the central point of the outbreak. In the United States, the number of cases stood at 15, with no deaths reported.

While the dynamics of the 2019 novel coronavirus are still being learned, the estimated range of spread for droplet transmission is 2 meters, according to Dr. Maves. The duration of environmental persistence is not yet known, but he said that other coronaviruses persist in low-humidity conditions for up to 4 days.

The number of secondary cases that arise from a primary infection, or R0, is estimated to be between 1.5 and 3, though it can change as exposure evolves; by comparison, the R0 for H1N1 influenza has been reported as 1.5, while measles is 12-18, indicating that it is “very contagious,” said Dr. Maves. Severe acute respiratory syndrome had an initial R0 of about 3.5, which he said declined rapidly to 0.7 as environmental and policy controls were put into place.

Critical care professionals need to know how to identify patients at risk of having COVID-19 and determine whether they need further work-up, according to Dr. Maves, who highlighted recent criteria released by the Centers for Disease Control and Prevention.

The highest-risk category, he said, are individuals exposed to a laboratory-confirmed coronavirus case, which along with fever or signs and symptoms of a lower respiratory illness would be sufficient to classify them as a “person of interest” requiring further evaluation for disease. A history of travel from Hubei Province plus fever and signs/symptoms of lower respiratory illness would also meet criteria for evaluation, according to the CDC, while travel to mainland China would also meet the threshold, if those symptoms required hospitalization.

The CDC also published a step-wise flowchart to evaluate patients who may have been exposed to the 2019 novel coronavirus. According to that flowchart, if an individual has traveled to China or had close contact with someone infected with the 2019 Novel Coronavirus within 14 days of symptoms, and that individual has fever or symptoms of lower respiratory illness such as cough or shortness of breath, then providers should isolate that individual and assess clinical status, in addition to contacting the local health department.

Andrew Bowser/MDedge News

Laura E. Evans, MD, MS, FCCM, of New York University, said she might recommend providers “flip the script” on that CDC algorithm when it comes to identifying patients who may have been exposed.

“I think perhaps what we should be doing at sites of entry is not talking about travel as the first question, but rather fever or symptoms of lower respiratory illnesses as the first question, and use that as the opportunity to implement risk mitigation at that stage,” Dr. Evans said in a presentation on preparing for COVID-19.

Even with “substantial uncertainty” about the potential impact of the 2019 Novel Coronavirus, a significant influx of seriously ill patients would put strain the U.S. health care delivery system, she added.

“None of us have tons of extra capacity in our emergency departments, inpatient units, or ICUs, and I think we need to be prepared for that,” she added. “We need to know what our process is for ‘identify, isolate, and inform,’ and we need to be testing that now.”

Dr. Maves and Dr. Evans both reported that they had no financial conflicts of interest to report. Dr. Maves indicated that the views expressed in his presentation did not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States government.

*Correction, 2/19/20: An earlier version of this article misstated the location of the naval center.

The ability to control the delivery of ventilation to patients having the acute respiratory distress syndrome (ARDS) without encountering patient respiratory effort via the administration of neuromuscular blocking drugs has been a potentially appealing therapeutic option for decades (Light RW, et al. Anesth Analg. 1975;54[2]:219). This practice had been common in the late 20th century in order to avoid excessive tachypnea and appearance of patient discomfort with the collateral benefit of improving oxygenation and decreasing the fraction of inspired oxygen (FiO₂) (Hansen-Flaschen JH, et al. JAMA. 1991;26:2870). Following the publication by the NIH-sponsored ARDS Network of the landmark low tidal volume lung protective ventilation trial, whereupon study subjects had been allowed to breathe up to 35 times per minute (ARDS Network, N Engl J Med. 2000;342[18]:1301) and additional concerns that neuromuscular blockade could potentially be associated with neuromuscular weakness, this practice fell out of favor.

Although the validity of using lung protective ventilation in ARDS, with a plateau pressure of less than 30 cm/H₂O via delivery of a low tidal volume, has withstood the test of time, subsequent attempts to utilize methods that would further protect the lung with additional “rescue” approaches to mechanical ventilation led to a partial renaissance of the neuromuscular blockade (NMB) approach. For example, high frequency oscillatory ventilation, with its idiosyncratic delivery of minute volumes of ventilator gas, requires NMB in order to be used. However, the publication of two negative trials, including one demonstrating an increased mortality, sidelined this approach (Ferguson ND, et al. N Engl J Med. 2013;368[9]:795).

More notably, the use of NMB in patients with ARDS has been advocated during conventional mechanical ventilation to avoid the generation of large tidal volumes via ventilator asynchrony occurring during patient-triggered breaths. Ostensibly, wiping out any patient effort via NMB eliminates manifestations of asynchrony, such as double triggering, which can generate areas of regional tidal hyperinflation in the injured lung and thereby worsen ventilator-induced lung injury. The utilization of NMB early in the course of ARDS (less than 48 hours) resulted in less lung inflammation (Forel JM, et al. Crit Care Med. 2006;34[11]:2749). Subsequently, the ACURASYS trial found that patients with moderately severe or severe ARDS treated with NMB had a mortality benefit comparable to that seen in the original ARDS low tidal volume trial (Papazian L, et al. N Engl J Med. 2010;369:980).

Several criticisms of ACURASYS led to the desire for a larger confirmatory trial be undertaken. The NIH-sponsored successor to the ARDS Network, the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, took this on straight away with its formation in 2014 (disclosure: the author is a Principal Investigator of one of the 13 PETAL Network Clinical Centers). This trial, called the Re-Evaluation of Systemic Early Neuromuscular Blockade, the ROSE trial, was published last year in the New England Journal of Medicine and failed to confirm a mortality benefit to NMB when used early in the course of ARDS, such as had been done earlier (Moss M, et al. N Engl J Med. 2019;380[21]:1997).

What then, should clinicians consider the proper use of NMB in ARDS to be?

There has been a recent spate of large negative trials of once-promising interventions in critical care medicine (Laffey. Lancet Respir Med. 2018;6[9]659). Among these were trials related to early mobility, vitamin D administration, transpulmonary pressure titrated positive end-expiratory pressure (PEEP), and of course, high frequency oscillatory ventilation, just to name a few disappointments. Recognition of heterogeneity of treatment effect (HTE), with some subgroups being more likely to respond to an intervention than others (Iwashyna. Am J Respir Crit Care Med. 2015;192[9]:1045), is cold comfort to the bedside clinician and all but the most dedicated health services researcher. At least to date, personalized medicine has fallen short of prospective validation in ARDS (Constantin et al. Lancet Respir Med. 2019;7[10]:870).

The failure of the ROSE trial to demonstrate a mortality benefit to ARDS patients with a P/F ratio of less than 150 on at least 8 cm H₂O treated with early NMB means the routine use of this approach in all such patients isn’t warranted. In a prescient nod to HTE, “a foolish consistency,” as Emerson said, “is the hobgoblin of little minds.” Importantly, there were several subtle but not necessarily irrelevant differences between ACURASYS and ROSE. ROSE used a high PEEP algorithm to titrate PEEP to FiO₂, rather than the conventional low PEEP approach used in the original ARDS Network and ACURASYS trials. Potentially, the benefits of NMB on the injured lung in ARDS may have been mitigated by using higher PEEP levels. ROSE also failed to demonstrate a decrease in barotrauma as had been reported earlier. That said, it is difficult to ascribe the lack of benefit of NMB mechanistically to less asynchrony induced regional tidal hyperinflation in the NMB group at high PEEP, especially given the lighter sedation targets employed in both the NMB and the placebo group. Meanwhile, ROSE did confirm patients were not harmed by NMB by resulting in more neuromuscular weakness upon recovery.

Among patients with Berlin severe ARDS (ie. P/F less than 100 on at least 5 cm H₂O PEEP) evaluated between publication of ACURASYS and ROSE, clinicians were far more inclined to use NMB than other rescue modalities, including prone ventilation (Duan, Ann Am Thorac Soc. 2017;12:1818). It seems unlikely the publication of ROSE will alter this. As rescue modalities go, NMB is relatively inexpensive, widely available and easily performed (Co, I and Hyzy RC, Crit Care Med. 2019 Dec 18. doi: 10.1097/CCM.0000000000004198). Ultimately, though the question isn’t whether NMB will be used in ARDS patients with refractory hypoxemia early or even later, but whether prone ventilation should be simultaneously initiated at the time of, or even before the institution of NMB.

As in ACURASYS, patients in the landmark PROSEVA prone ventilation trial were treated with a low PEEP algorithm (Guérin C et al. N Engl J Med. 2013;368[23]:2159). Prone ventilation has many salutary physiologic benefits, not the least of which is recruitment of areas of collapsed lung. Patients who are recruitable with PEEP, i.e. whose PaO₂ increases with increasing PEEP in the face of an unchanged or minimally changed plateau pressure, may also demonstrate a mortality benefit (Goligher, EC et al. Am J Respir Crit Care Med. 2014;190[1]:70). It remains unknown whether prone ventilation would remain of significant benefit should a high PEEP approach be employed.

Prone ventilation clearly has its adherents (Albert, RK, Ann Am Thorac Soc. 2020;17[1]:24), although underutilization remains prevalent perhaps due to its somewhat cumbersome nature. While it might have been interesting had ROSE performed a simultaneous assessment of prone ventilation along with NMB via a factorial trial design, clinicians remain at the crossroads of how to escalate ventilator support in the ARDS patient with worsening, if not refractory hypoxemia. The use of NMB with a high PEEP approach often allows for recruitment and a concomitant lowering of FiO₂ to acceptable levels in advance of the utilization of prone ventilation. Although some clinicians are able to successfully utilize prone ventilation without NMB, many are not, and NMB use was widespread in PROSEVA.

With no evidence of harm, the employment of NMB in the setting of Berlin severe ARDS is entirely justifiable, whether occurring early or late in the clinical course, regardless of, or potentially with the concomitant employment of prone ventilation. These two rescue modalities remain first line and, despite evidence to the contrary (Li, et al. Am J Respir Crit Care Med. 2018;197[8]:991) should be employed in advance of others, most notably extracorporeal support.
 

Dr. Hyzy is with the Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor.

The ability to control the delivery of ventilation to patients having the acute respiratory distress syndrome (ARDS) without encountering patient respiratory effort via the administration of neuromuscular blocking drugs has been a potentially appealing therapeutic option for decades (Light RW, et al. Anesth Analg. 1975;54[2]:219). This practice had been common in the late 20th century in order to avoid excessive tachypnea and appearance of patient discomfort with the collateral benefit of improving oxygenation and decreasing the fraction of inspired oxygen (FiO₂) (Hansen-Flaschen JH, et al. JAMA. 1991;26:2870). Following the publication by the NIH-sponsored ARDS Network of the landmark low tidal volume lung protective ventilation trial, whereupon study subjects had been allowed to breathe up to 35 times per minute (ARDS Network, N Engl J Med. 2000;342[18]:1301) and additional concerns that neuromuscular blockade could potentially be associated with neuromuscular weakness, this practice fell out of favor.

Although the validity of using lung protective ventilation in ARDS, with a plateau pressure of less than 30 cm/H₂O via delivery of a low tidal volume, has withstood the test of time, subsequent attempts to utilize methods that would further protect the lung with additional “rescue” approaches to mechanical ventilation led to a partial renaissance of the neuromuscular blockade (NMB) approach. For example, high frequency oscillatory ventilation, with its idiosyncratic delivery of minute volumes of ventilator gas, requires NMB in order to be used. However, the publication of two negative trials, including one demonstrating an increased mortality, sidelined this approach (Ferguson ND, et al. N Engl J Med. 2013;368[9]:795).

More notably, the use of NMB in patients with ARDS has been advocated during conventional mechanical ventilation to avoid the generation of large tidal volumes via ventilator asynchrony occurring during patient-triggered breaths. Ostensibly, wiping out any patient effort via NMB eliminates manifestations of asynchrony, such as double triggering, which can generate areas of regional tidal hyperinflation in the injured lung and thereby worsen ventilator-induced lung injury. The utilization of NMB early in the course of ARDS (less than 48 hours) resulted in less lung inflammation (Forel JM, et al. Crit Care Med. 2006;34[11]:2749). Subsequently, the ACURASYS trial found that patients with moderately severe or severe ARDS treated with NMB had a mortality benefit comparable to that seen in the original ARDS low tidal volume trial (Papazian L, et al. N Engl J Med. 2010;369:980).

Several criticisms of ACURASYS led to the desire for a larger confirmatory trial be undertaken. The NIH-sponsored successor to the ARDS Network, the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, took this on straight away with its formation in 2014 (disclosure: the author is a Principal Investigator of one of the 13 PETAL Network Clinical Centers). This trial, called the Re-Evaluation of Systemic Early Neuromuscular Blockade, the ROSE trial, was published last year in the New England Journal of Medicine and failed to confirm a mortality benefit to NMB when used early in the course of ARDS, such as had been done earlier (Moss M, et al. N Engl J Med. 2019;380[21]:1997).

What then, should clinicians consider the proper use of NMB in ARDS to be?

There has been a recent spate of large negative trials of once-promising interventions in critical care medicine (Laffey. Lancet Respir Med. 2018;6[9]659). Among these were trials related to early mobility, vitamin D administration, transpulmonary pressure titrated positive end-expiratory pressure (PEEP), and of course, high frequency oscillatory ventilation, just to name a few disappointments. Recognition of heterogeneity of treatment effect (HTE), with some subgroups being more likely to respond to an intervention than others (Iwashyna. Am J Respir Crit Care Med. 2015;192[9]:1045), is cold comfort to the bedside clinician and all but the most dedicated health services researcher. At least to date, personalized medicine has fallen short of prospective validation in ARDS (Constantin et al. Lancet Respir Med. 2019;7[10]:870).

The failure of the ROSE trial to demonstrate a mortality benefit to ARDS patients with a P/F ratio of less than 150 on at least 8 cm H₂O treated with early NMB means the routine use of this approach in all such patients isn’t warranted. In a prescient nod to HTE, “a foolish consistency,” as Emerson said, “is the hobgoblin of little minds.” Importantly, there were several subtle but not necessarily irrelevant differences between ACURASYS and ROSE. ROSE used a high PEEP algorithm to titrate PEEP to FiO₂, rather than the conventional low PEEP approach used in the original ARDS Network and ACURASYS trials. Potentially, the benefits of NMB on the injured lung in ARDS may have been mitigated by using higher PEEP levels. ROSE also failed to demonstrate a decrease in barotrauma as had been reported earlier. That said, it is difficult to ascribe the lack of benefit of NMB mechanistically to less asynchrony induced regional tidal hyperinflation in the NMB group at high PEEP, especially given the lighter sedation targets employed in both the NMB and the placebo group. Meanwhile, ROSE did confirm patients were not harmed by NMB by resulting in more neuromuscular weakness upon recovery.

Among patients with Berlin severe ARDS (ie. P/F less than 100 on at least 5 cm H₂O PEEP) evaluated between publication of ACURASYS and ROSE, clinicians were far more inclined to use NMB than other rescue modalities, including prone ventilation (Duan, Ann Am Thorac Soc. 2017;12:1818). It seems unlikely the publication of ROSE will alter this. As rescue modalities go, NMB is relatively inexpensive, widely available and easily performed (Co, I and Hyzy RC, Crit Care Med. 2019 Dec 18. doi: 10.1097/CCM.0000000000004198). Ultimately, though the question isn’t whether NMB will be used in ARDS patients with refractory hypoxemia early or even later, but whether prone ventilation should be simultaneously initiated at the time of, or even before the institution of NMB.

As in ACURASYS, patients in the landmark PROSEVA prone ventilation trial were treated with a low PEEP algorithm (Guérin C et al. N Engl J Med. 2013;368[23]:2159). Prone ventilation has many salutary physiologic benefits, not the least of which is recruitment of areas of collapsed lung. Patients who are recruitable with PEEP, i.e. whose PaO₂ increases with increasing PEEP in the face of an unchanged or minimally changed plateau pressure, may also demonstrate a mortality benefit (Goligher, EC et al. Am J Respir Crit Care Med. 2014;190[1]:70). It remains unknown whether prone ventilation would remain of significant benefit should a high PEEP approach be employed.

Prone ventilation clearly has its adherents (Albert, RK, Ann Am Thorac Soc. 2020;17[1]:24), although underutilization remains prevalent perhaps due to its somewhat cumbersome nature. While it might have been interesting had ROSE performed a simultaneous assessment of prone ventilation along with NMB via a factorial trial design, clinicians remain at the crossroads of how to escalate ventilator support in the ARDS patient with worsening, if not refractory hypoxemia. The use of NMB with a high PEEP approach often allows for recruitment and a concomitant lowering of FiO₂ to acceptable levels in advance of the utilization of prone ventilation. Although some clinicians are able to successfully utilize prone ventilation without NMB, many are not, and NMB use was widespread in PROSEVA.

With no evidence of harm, the employment of NMB in the setting of Berlin severe ARDS is entirely justifiable, whether occurring early or late in the clinical course, regardless of, or potentially with the concomitant employment of prone ventilation. These two rescue modalities remain first line and, despite evidence to the contrary (Li, et al. Am J Respir Crit Care Med. 2018;197[8]:991) should be employed in advance of others, most notably extracorporeal support.
 

Dr. Hyzy is with the Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor.

The ability to control the delivery of ventilation to patients having the acute respiratory distress syndrome (ARDS) without encountering patient respiratory effort via the administration of neuromuscular blocking drugs has been a potentially appealing therapeutic option for decades (Light RW, et al. Anesth Analg. 1975;54[2]:219). This practice had been common in the late 20th century in order to avoid excessive tachypnea and appearance of patient discomfort with the collateral benefit of improving oxygenation and decreasing the fraction of inspired oxygen (FiO₂) (Hansen-Flaschen JH, et al. JAMA. 1991;26:2870). Following the publication by the NIH-sponsored ARDS Network of the landmark low tidal volume lung protective ventilation trial, whereupon study subjects had been allowed to breathe up to 35 times per minute (ARDS Network, N Engl J Med. 2000;342[18]:1301) and additional concerns that neuromuscular blockade could potentially be associated with neuromuscular weakness, this practice fell out of favor.

Although the validity of using lung protective ventilation in ARDS, with a plateau pressure of less than 30 cm/H₂O via delivery of a low tidal volume, has withstood the test of time, subsequent attempts to utilize methods that would further protect the lung with additional “rescue” approaches to mechanical ventilation led to a partial renaissance of the neuromuscular blockade (NMB) approach. For example, high frequency oscillatory ventilation, with its idiosyncratic delivery of minute volumes of ventilator gas, requires NMB in order to be used. However, the publication of two negative trials, including one demonstrating an increased mortality, sidelined this approach (Ferguson ND, et al. N Engl J Med. 2013;368[9]:795).

More notably, the use of NMB in patients with ARDS has been advocated during conventional mechanical ventilation to avoid the generation of large tidal volumes via ventilator asynchrony occurring during patient-triggered breaths. Ostensibly, wiping out any patient effort via NMB eliminates manifestations of asynchrony, such as double triggering, which can generate areas of regional tidal hyperinflation in the injured lung and thereby worsen ventilator-induced lung injury. The utilization of NMB early in the course of ARDS (less than 48 hours) resulted in less lung inflammation (Forel JM, et al. Crit Care Med. 2006;34[11]:2749). Subsequently, the ACURASYS trial found that patients with moderately severe or severe ARDS treated with NMB had a mortality benefit comparable to that seen in the original ARDS low tidal volume trial (Papazian L, et al. N Engl J Med. 2010;369:980).

Several criticisms of ACURASYS led to the desire for a larger confirmatory trial be undertaken. The NIH-sponsored successor to the ARDS Network, the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, took this on straight away with its formation in 2014 (disclosure: the author is a Principal Investigator of one of the 13 PETAL Network Clinical Centers). This trial, called the Re-Evaluation of Systemic Early Neuromuscular Blockade, the ROSE trial, was published last year in the New England Journal of Medicine and failed to confirm a mortality benefit to NMB when used early in the course of ARDS, such as had been done earlier (Moss M, et al. N Engl J Med. 2019;380[21]:1997).

What then, should clinicians consider the proper use of NMB in ARDS to be?

There has been a recent spate of large negative trials of once-promising interventions in critical care medicine (Laffey. Lancet Respir Med. 2018;6[9]659). Among these were trials related to early mobility, vitamin D administration, transpulmonary pressure titrated positive end-expiratory pressure (PEEP), and of course, high frequency oscillatory ventilation, just to name a few disappointments. Recognition of heterogeneity of treatment effect (HTE), with some subgroups being more likely to respond to an intervention than others (Iwashyna. Am J Respir Crit Care Med. 2015;192[9]:1045), is cold comfort to the bedside clinician and all but the most dedicated health services researcher. At least to date, personalized medicine has fallen short of prospective validation in ARDS (Constantin et al. Lancet Respir Med. 2019;7[10]:870).

The failure of the ROSE trial to demonstrate a mortality benefit to ARDS patients with a P/F ratio of less than 150 on at least 8 cm H₂O treated with early NMB means the routine use of this approach in all such patients isn’t warranted. In a prescient nod to HTE, “a foolish consistency,” as Emerson said, “is the hobgoblin of little minds.” Importantly, there were several subtle but not necessarily irrelevant differences between ACURASYS and ROSE. ROSE used a high PEEP algorithm to titrate PEEP to FiO₂, rather than the conventional low PEEP approach used in the original ARDS Network and ACURASYS trials. Potentially, the benefits of NMB on the injured lung in ARDS may have been mitigated by using higher PEEP levels. ROSE also failed to demonstrate a decrease in barotrauma as had been reported earlier. That said, it is difficult to ascribe the lack of benefit of NMB mechanistically to less asynchrony induced regional tidal hyperinflation in the NMB group at high PEEP, especially given the lighter sedation targets employed in both the NMB and the placebo group. Meanwhile, ROSE did confirm patients were not harmed by NMB by resulting in more neuromuscular weakness upon recovery.

Among patients with Berlin severe ARDS (ie. P/F less than 100 on at least 5 cm H₂O PEEP) evaluated between publication of ACURASYS and ROSE, clinicians were far more inclined to use NMB than other rescue modalities, including prone ventilation (Duan, Ann Am Thorac Soc. 2017;12:1818). It seems unlikely the publication of ROSE will alter this. As rescue modalities go, NMB is relatively inexpensive, widely available and easily performed (Co, I and Hyzy RC, Crit Care Med. 2019 Dec 18. doi: 10.1097/CCM.0000000000004198). Ultimately, though the question isn’t whether NMB will be used in ARDS patients with refractory hypoxemia early or even later, but whether prone ventilation should be simultaneously initiated at the time of, or even before the institution of NMB.

As in ACURASYS, patients in the landmark PROSEVA prone ventilation trial were treated with a low PEEP algorithm (Guérin C et al. N Engl J Med. 2013;368[23]:2159). Prone ventilation has many salutary physiologic benefits, not the least of which is recruitment of areas of collapsed lung. Patients who are recruitable with PEEP, i.e. whose PaO₂ increases with increasing PEEP in the face of an unchanged or minimally changed plateau pressure, may also demonstrate a mortality benefit (Goligher, EC et al. Am J Respir Crit Care Med. 2014;190[1]:70). It remains unknown whether prone ventilation would remain of significant benefit should a high PEEP approach be employed.

Prone ventilation clearly has its adherents (Albert, RK, Ann Am Thorac Soc. 2020;17[1]:24), although underutilization remains prevalent perhaps due to its somewhat cumbersome nature. While it might have been interesting had ROSE performed a simultaneous assessment of prone ventilation along with NMB via a factorial trial design, clinicians remain at the crossroads of how to escalate ventilator support in the ARDS patient with worsening, if not refractory hypoxemia. The use of NMB with a high PEEP approach often allows for recruitment and a concomitant lowering of FiO₂ to acceptable levels in advance of the utilization of prone ventilation. Although some clinicians are able to successfully utilize prone ventilation without NMB, many are not, and NMB use was widespread in PROSEVA.

With no evidence of harm, the employment of NMB in the setting of Berlin severe ARDS is entirely justifiable, whether occurring early or late in the clinical course, regardless of, or potentially with the concomitant employment of prone ventilation. These two rescue modalities remain first line and, despite evidence to the contrary (Li, et al. Am J Respir Crit Care Med. 2018;197[8]:991) should be employed in advance of others, most notably extracorporeal support.
 

Dr. Hyzy is with the Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor.

Clinicians managing patients who have Candida bloodstream infection should consider an infectious disease (ID) consultation, findings from a large retrospective study suggest.

GrahamColm/Wikimedia Commons

Mortality attributable to Candida bloodstream infection ranges between 15% and 47%, and delay in initiation of appropriate treatment has been associated with increased mortality. Previous small studies showed that ID consultation has conferred benefits to patients with Candida bloodstream infections. Carlos Mejia-Chew, MD, and colleagues from Washington University, St. Louis, sought to explore this further by performing a retrospective, single-center cohort study of 1,691 patients aged 18 years or older with Candida bloodstream infection from 2002 to 2015. They analyzed demographics, comorbidities, predisposing factors, all-cause mortality, antifungal use, central-line removal, and ophthalmological and echocardiographic evaluation in order to compare 90-day all-cause mortality between individuals with and without an ID consultation.

They found that those patients who received an ID consult for a Candida bloodstream infection had a significantly lower 90-day mortality rate than did those who did not (29% vs. 51%).

With a model using inverse weighting by the propensity score, they found that ID consultation was associated with a hazard ratio of 0.81 for mortality (95% confidence interval, 0.73-0.91; P less than .0001). In the ID consultation group, the median duration of antifungal therapy was significantly longer (18 vs. 14 days; P less than .0001); central-line removal was significantly more common (76% vs. 59%; P less than .0001); echocardiography use was more frequent (57% vs. 33%; P less than .0001); and ophthalmological examinations were performed more often (53% vs. 17%; P less than .0001). Importantly, fewer patients in the ID consultation group were untreated (2% vs. 14%; P less than .0001).

In an accompanying commentary, Katrien Lagrou, MD, and Eric Van Wijngaerden, MD, of the department of microbiology, immunology and transplantation, University Hospitals Leuven (Belgium) stated: “We think that the high proportion of patients (14%) with a Candida bloodstream infection who did not receive any antifungal treatment and did not have an infectious disease consultation is a particularly alarming finding. ... Ninety-day mortality in these untreated patients was high (67%).”

“We believe every hospital should have an expert management strategy addressing all individual cases of candidaemia. The need for such expert management should be incorporated in all future candidaemia management guidelines,” they concluded.

The study was funded by the Astellas Global Development Pharma, the Washington University Institute of Clinical and Translational Sciences, and the Agency for Healthcare Research and Quality. Several of the authors had financial connections to Astellas Global Development or other pharmaceutical companies. Dr. Lagrou and Dr. Van Wijngaerden both reported receiving personal fees and nonfinancial support from a number of pharmaceutical companies, but all outside the scope of the study.

[email protected]

SOURCE: Mejia-Chew C et al. Lancet Infect Dis. 2019;19:1336-44.

Clinicians managing patients who have Candida bloodstream infection should consider an infectious disease (ID) consultation, findings from a large retrospective study suggest.

GrahamColm/Wikimedia Commons

Mortality attributable to Candida bloodstream infection ranges between 15% and 47%, and delay in initiation of appropriate treatment has been associated with increased mortality. Previous small studies showed that ID consultation has conferred benefits to patients with Candida bloodstream infections. Carlos Mejia-Chew, MD, and colleagues from Washington University, St. Louis, sought to explore this further by performing a retrospective, single-center cohort study of 1,691 patients aged 18 years or older with Candida bloodstream infection from 2002 to 2015. They analyzed demographics, comorbidities, predisposing factors, all-cause mortality, antifungal use, central-line removal, and ophthalmological and echocardiographic evaluation in order to compare 90-day all-cause mortality between individuals with and without an ID consultation.

They found that those patients who received an ID consult for a Candida bloodstream infection had a significantly lower 90-day mortality rate than did those who did not (29% vs. 51%).

With a model using inverse weighting by the propensity score, they found that ID consultation was associated with a hazard ratio of 0.81 for mortality (95% confidence interval, 0.73-0.91; P less than .0001). In the ID consultation group, the median duration of antifungal therapy was significantly longer (18 vs. 14 days; P less than .0001); central-line removal was significantly more common (76% vs. 59%; P less than .0001); echocardiography use was more frequent (57% vs. 33%; P less than .0001); and ophthalmological examinations were performed more often (53% vs. 17%; P less than .0001). Importantly, fewer patients in the ID consultation group were untreated (2% vs. 14%; P less than .0001).

In an accompanying commentary, Katrien Lagrou, MD, and Eric Van Wijngaerden, MD, of the department of microbiology, immunology and transplantation, University Hospitals Leuven (Belgium) stated: “We think that the high proportion of patients (14%) with a Candida bloodstream infection who did not receive any antifungal treatment and did not have an infectious disease consultation is a particularly alarming finding. ... Ninety-day mortality in these untreated patients was high (67%).”

“We believe every hospital should have an expert management strategy addressing all individual cases of candidaemia. The need for such expert management should be incorporated in all future candidaemia management guidelines,” they concluded.

The study was funded by the Astellas Global Development Pharma, the Washington University Institute of Clinical and Translational Sciences, and the Agency for Healthcare Research and Quality. Several of the authors had financial connections to Astellas Global Development or other pharmaceutical companies. Dr. Lagrou and Dr. Van Wijngaerden both reported receiving personal fees and nonfinancial support from a number of pharmaceutical companies, but all outside the scope of the study.

[email protected]

SOURCE: Mejia-Chew C et al. Lancet Infect Dis. 2019;19:1336-44.

Clinicians managing patients who have Candida bloodstream infection should consider an infectious disease (ID) consultation, findings from a large retrospective study suggest.

GrahamColm/Wikimedia Commons

Mortality attributable to Candida bloodstream infection ranges between 15% and 47%, and delay in initiation of appropriate treatment has been associated with increased mortality. Previous small studies showed that ID consultation has conferred benefits to patients with Candida bloodstream infections. Carlos Mejia-Chew, MD, and colleagues from Washington University, St. Louis, sought to explore this further by performing a retrospective, single-center cohort study of 1,691 patients aged 18 years or older with Candida bloodstream infection from 2002 to 2015. They analyzed demographics, comorbidities, predisposing factors, all-cause mortality, antifungal use, central-line removal, and ophthalmological and echocardiographic evaluation in order to compare 90-day all-cause mortality between individuals with and without an ID consultation.

They found that those patients who received an ID consult for a Candida bloodstream infection had a significantly lower 90-day mortality rate than did those who did not (29% vs. 51%).

With a model using inverse weighting by the propensity score, they found that ID consultation was associated with a hazard ratio of 0.81 for mortality (95% confidence interval, 0.73-0.91; P less than .0001). In the ID consultation group, the median duration of antifungal therapy was significantly longer (18 vs. 14 days; P less than .0001); central-line removal was significantly more common (76% vs. 59%; P less than .0001); echocardiography use was more frequent (57% vs. 33%; P less than .0001); and ophthalmological examinations were performed more often (53% vs. 17%; P less than .0001). Importantly, fewer patients in the ID consultation group were untreated (2% vs. 14%; P less than .0001).

In an accompanying commentary, Katrien Lagrou, MD, and Eric Van Wijngaerden, MD, of the department of microbiology, immunology and transplantation, University Hospitals Leuven (Belgium) stated: “We think that the high proportion of patients (14%) with a Candida bloodstream infection who did not receive any antifungal treatment and did not have an infectious disease consultation is a particularly alarming finding. ... Ninety-day mortality in these untreated patients was high (67%).”

“We believe every hospital should have an expert management strategy addressing all individual cases of candidaemia. The need for such expert management should be incorporated in all future candidaemia management guidelines,” they concluded.

The study was funded by the Astellas Global Development Pharma, the Washington University Institute of Clinical and Translational Sciences, and the Agency for Healthcare Research and Quality. Several of the authors had financial connections to Astellas Global Development or other pharmaceutical companies. Dr. Lagrou and Dr. Van Wijngaerden both reported receiving personal fees and nonfinancial support from a number of pharmaceutical companies, but all outside the scope of the study.

[email protected]

SOURCE: Mejia-Chew C et al. Lancet Infect Dis. 2019;19:1336-44.

The Uniform Determination of Death Act (UDDA) should be revised to clarify and harmonize procedures related to the determination of death by neurologic criteria, according to an editorial published online Dec. 24, 2019, in Annals of Internal Medicine. Proposed revisions would identify the standards for determining death by neurologic criteria and address the question of whether consent is required to make this determination. If accepted, the revisions would enhance public trust in the determination of death by neurologic criteria, the authors said.

Edwin Verin/©Thinkstock

“There is a disconnect between the medical and legal standards for brain death,” said Ariane K. Lewis, MD, associate professor of neurology and neurosurgery at New York University and lead author of the editorial. The discrepancy must be remedied because it has led to lawsuits and has proved to be problematic from a societal standpoint, she added.

“We defend changing the law to match medical practice, rather than changing medical practice to match the law,” said Thaddeus Mason Pope, JD, PhD, director of the Health Law Institute at Mitchell Hamline School of Law in Saint Paul, Minnesota, and an author of the editorial.
 

Accepted medical standards are unclear

The UDDA was drafted in 1981 to establish a uniform legal standard for death by neurologic criteria. A person with “irreversible cessation of all functions of the entire brain, including the brainstem,” is dead, according to the statute. A determination of death, it adds, “must be made in accordance with accepted medical standards.”

But the medical standards used to determine death by neurologic cause have not been uniform. In 2015, the Supreme Court of Nevada ruled that it was not clear that the standard published by the American Academy of Neurology (AAN), which had been used in the case at issue, was the “accepted medical standard.” An AAN summit later affirmed that the accepted medical standards for determination of death by neurologic cause are the 2010 AAN standard for determination of brain death in adults and the 2011 Society of Critical Care Medicine (SCCM), American Academy of Pediatrics (AAP), and Child Neurology Society (CNS) standard for determination of brain death in children. The Nevada legislature amended the state UDDA to identify these standards as the accepted standards. A revised UDDA also should identify these standards and grant an administrative agency (i.e., the board of medicine) the power to review and update the accepted medical standards as needed, according to the editorial.

To the extent that hospitals are not following the AAN or SCCM/AAP/CNS standards for determining death by neurologic cause, “enshrining” these standards in a revised UDDA “should increase uniformity and consistency” in hospitals’ policies on brain death, Dr. Pope said.
 

The question of hormonal function

Lawsuits in California and Nevada raised the question of whether the pituitary gland and hypothalamus are parts of the brain. If so, then the accepted medical standards for death by neurologic cause are not consistent with the statutory requirements for the determination of death, since the former do not test for cessation of hormonal function.

The current edition of the adult standards for determining death by neurologic cause were published in 2010. “Whenever we measure brain death, we’re not measuring the cessation of all functions of the entire brain,” Dr. Pope said. “That’s not a new thing; that’s been the case for a long time.”

To address the discrepancy between medical practice and the legal statute, Dr. Lewis and colleagues proposed that the UDDA’s reference to “irreversible cessation of functions of the entire brain” be followed by the following clause: “including the brainstem, leading to unresponsive coma with loss of capacity for consciousness, brainstem areflexia, and the inability to breathe spontaneously.” An alternative revision would be to add the briefer phrase “... with the exception of hormonal function.”
 

Authors say consent is not required for testing

Other complications have arisen from the UDDA’s failure to specify whether consent is required for a determination of death by neurologic cause. Court rulings on this question have not been consistent. Dr. Lewis and colleagues propose adding the following text to the UDDA: “Reasonable efforts should be made to notify a patient’s legally authorized decision-maker before performing a determination of death by neurologic criteria, but consent is not required to initiate such an evaluation.”

The proposed revisions to the UDDA “might give [clinicians] more confidence to proceed with brain death testing, because it would clarify that they don’t need the parents’ [or the patient’s legally authorized decision-maker] consent to do the tests,” said Dr. Pope. “If anything, they might even have a duty to do the tests.”

The final problem with the UDDA that Dr. Lewis and colleagues cited is that it does not provide clear guidance about how to respond to religious objections to discontinuation of organ support after a determination of death by neurologic cause. “Because the issue is rather complicated, we have not advocated for a singular position related to this [question] in our revised UDDA,” Dr. Lewis said. “Rather, we recommended the need for a multidisciplinary group to come together to determine what is the best approach. In an ideal world, this [approach] would be universal throughout the country.”

Although a revised UDDA would provide greater clarity to physicians and promote uniformity of practice, it would not resolve ongoing theological and philosophical debates about whether brain death is biological death, Dr. Pope said. “The key thing is that it would give clinicians a green light or certainty and clarity that they may proceed to do the test in the first place. If the tests are positive and the patient really is dead, then they could proceed to organ procurement or to move to the morgue.”

Dr. Lewis is a member of various AAN committees and working groups but receives no compensation for her role. A coauthor received personal fees from the AAN that were unrelated to the editorial.

[email protected]

SOURCE: Lewis A et al. Ann Intern Med. 2019 Dec 24. doi: 10.7326/M19-2731.

The Uniform Determination of Death Act (UDDA) should be revised to clarify and harmonize procedures related to the determination of death by neurologic criteria, according to an editorial published online Dec. 24, 2019, in Annals of Internal Medicine. Proposed revisions would identify the standards for determining death by neurologic criteria and address the question of whether consent is required to make this determination. If accepted, the revisions would enhance public trust in the determination of death by neurologic criteria, the authors said.

Edwin Verin/©Thinkstock

“There is a disconnect between the medical and legal standards for brain death,” said Ariane K. Lewis, MD, associate professor of neurology and neurosurgery at New York University and lead author of the editorial. The discrepancy must be remedied because it has led to lawsuits and has proved to be problematic from a societal standpoint, she added.

“We defend changing the law to match medical practice, rather than changing medical practice to match the law,” said Thaddeus Mason Pope, JD, PhD, director of the Health Law Institute at Mitchell Hamline School of Law in Saint Paul, Minnesota, and an author of the editorial.
 

Accepted medical standards are unclear

The UDDA was drafted in 1981 to establish a uniform legal standard for death by neurologic criteria. A person with “irreversible cessation of all functions of the entire brain, including the brainstem,” is dead, according to the statute. A determination of death, it adds, “must be made in accordance with accepted medical standards.”

But the medical standards used to determine death by neurologic cause have not been uniform. In 2015, the Supreme Court of Nevada ruled that it was not clear that the standard published by the American Academy of Neurology (AAN), which had been used in the case at issue, was the “accepted medical standard.” An AAN summit later affirmed that the accepted medical standards for determination of death by neurologic cause are the 2010 AAN standard for determination of brain death in adults and the 2011 Society of Critical Care Medicine (SCCM), American Academy of Pediatrics (AAP), and Child Neurology Society (CNS) standard for determination of brain death in children. The Nevada legislature amended the state UDDA to identify these standards as the accepted standards. A revised UDDA also should identify these standards and grant an administrative agency (i.e., the board of medicine) the power to review and update the accepted medical standards as needed, according to the editorial.

To the extent that hospitals are not following the AAN or SCCM/AAP/CNS standards for determining death by neurologic cause, “enshrining” these standards in a revised UDDA “should increase uniformity and consistency” in hospitals’ policies on brain death, Dr. Pope said.
 

The question of hormonal function

Lawsuits in California and Nevada raised the question of whether the pituitary gland and hypothalamus are parts of the brain. If so, then the accepted medical standards for death by neurologic cause are not consistent with the statutory requirements for the determination of death, since the former do not test for cessation of hormonal function.

The current edition of the adult standards for determining death by neurologic cause were published in 2010. “Whenever we measure brain death, we’re not measuring the cessation of all functions of the entire brain,” Dr. Pope said. “That’s not a new thing; that’s been the case for a long time.”

To address the discrepancy between medical practice and the legal statute, Dr. Lewis and colleagues proposed that the UDDA’s reference to “irreversible cessation of functions of the entire brain” be followed by the following clause: “including the brainstem, leading to unresponsive coma with loss of capacity for consciousness, brainstem areflexia, and the inability to breathe spontaneously.” An alternative revision would be to add the briefer phrase “... with the exception of hormonal function.”
 

Authors say consent is not required for testing

Other complications have arisen from the UDDA’s failure to specify whether consent is required for a determination of death by neurologic cause. Court rulings on this question have not been consistent. Dr. Lewis and colleagues propose adding the following text to the UDDA: “Reasonable efforts should be made to notify a patient’s legally authorized decision-maker before performing a determination of death by neurologic criteria, but consent is not required to initiate such an evaluation.”

The proposed revisions to the UDDA “might give [clinicians] more confidence to proceed with brain death testing, because it would clarify that they don’t need the parents’ [or the patient’s legally authorized decision-maker] consent to do the tests,” said Dr. Pope. “If anything, they might even have a duty to do the tests.”

The final problem with the UDDA that Dr. Lewis and colleagues cited is that it does not provide clear guidance about how to respond to religious objections to discontinuation of organ support after a determination of death by neurologic cause. “Because the issue is rather complicated, we have not advocated for a singular position related to this [question] in our revised UDDA,” Dr. Lewis said. “Rather, we recommended the need for a multidisciplinary group to come together to determine what is the best approach. In an ideal world, this [approach] would be universal throughout the country.”

Although a revised UDDA would provide greater clarity to physicians and promote uniformity of practice, it would not resolve ongoing theological and philosophical debates about whether brain death is biological death, Dr. Pope said. “The key thing is that it would give clinicians a green light or certainty and clarity that they may proceed to do the test in the first place. If the tests are positive and the patient really is dead, then they could proceed to organ procurement or to move to the morgue.”

Dr. Lewis is a member of various AAN committees and working groups but receives no compensation for her role. A coauthor received personal fees from the AAN that were unrelated to the editorial.

[email protected]

SOURCE: Lewis A et al. Ann Intern Med. 2019 Dec 24. doi: 10.7326/M19-2731.

The Uniform Determination of Death Act (UDDA) should be revised to clarify and harmonize procedures related to the determination of death by neurologic criteria, according to an editorial published online Dec. 24, 2019, in Annals of Internal Medicine. Proposed revisions would identify the standards for determining death by neurologic criteria and address the question of whether consent is required to make this determination. If accepted, the revisions would enhance public trust in the determination of death by neurologic criteria, the authors said.

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“There is a disconnect between the medical and legal standards for brain death,” said Ariane K. Lewis, MD, associate professor of neurology and neurosurgery at New York University and lead author of the editorial. The discrepancy must be remedied because it has led to lawsuits and has proved to be problematic from a societal standpoint, she added.

“We defend changing the law to match medical practice, rather than changing medical practice to match the law,” said Thaddeus Mason Pope, JD, PhD, director of the Health Law Institute at Mitchell Hamline School of Law in Saint Paul, Minnesota, and an author of the editorial.
 

Accepted medical standards are unclear

The UDDA was drafted in 1981 to establish a uniform legal standard for death by neurologic criteria. A person with “irreversible cessation of all functions of the entire brain, including the brainstem,” is dead, according to the statute. A determination of death, it adds, “must be made in accordance with accepted medical standards.”

But the medical standards used to determine death by neurologic cause have not been uniform. In 2015, the Supreme Court of Nevada ruled that it was not clear that the standard published by the American Academy of Neurology (AAN), which had been used in the case at issue, was the “accepted medical standard.” An AAN summit later affirmed that the accepted medical standards for determination of death by neurologic cause are the 2010 AAN standard for determination of brain death in adults and the 2011 Society of Critical Care Medicine (SCCM), American Academy of Pediatrics (AAP), and Child Neurology Society (CNS) standard for determination of brain death in children. The Nevada legislature amended the state UDDA to identify these standards as the accepted standards. A revised UDDA also should identify these standards and grant an administrative agency (i.e., the board of medicine) the power to review and update the accepted medical standards as needed, according to the editorial.

To the extent that hospitals are not following the AAN or SCCM/AAP/CNS standards for determining death by neurologic cause, “enshrining” these standards in a revised UDDA “should increase uniformity and consistency” in hospitals’ policies on brain death, Dr. Pope said.
 

The question of hormonal function

Lawsuits in California and Nevada raised the question of whether the pituitary gland and hypothalamus are parts of the brain. If so, then the accepted medical standards for death by neurologic cause are not consistent with the statutory requirements for the determination of death, since the former do not test for cessation of hormonal function.

The current edition of the adult standards for determining death by neurologic cause were published in 2010. “Whenever we measure brain death, we’re not measuring the cessation of all functions of the entire brain,” Dr. Pope said. “That’s not a new thing; that’s been the case for a long time.”

To address the discrepancy between medical practice and the legal statute, Dr. Lewis and colleagues proposed that the UDDA’s reference to “irreversible cessation of functions of the entire brain” be followed by the following clause: “including the brainstem, leading to unresponsive coma with loss of capacity for consciousness, brainstem areflexia, and the inability to breathe spontaneously.” An alternative revision would be to add the briefer phrase “... with the exception of hormonal function.”
 

Authors say consent is not required for testing

Other complications have arisen from the UDDA’s failure to specify whether consent is required for a determination of death by neurologic cause. Court rulings on this question have not been consistent. Dr. Lewis and colleagues propose adding the following text to the UDDA: “Reasonable efforts should be made to notify a patient’s legally authorized decision-maker before performing a determination of death by neurologic criteria, but consent is not required to initiate such an evaluation.”

The proposed revisions to the UDDA “might give [clinicians] more confidence to proceed with brain death testing, because it would clarify that they don’t need the parents’ [or the patient’s legally authorized decision-maker] consent to do the tests,” said Dr. Pope. “If anything, they might even have a duty to do the tests.”

The final problem with the UDDA that Dr. Lewis and colleagues cited is that it does not provide clear guidance about how to respond to religious objections to discontinuation of organ support after a determination of death by neurologic cause. “Because the issue is rather complicated, we have not advocated for a singular position related to this [question] in our revised UDDA,” Dr. Lewis said. “Rather, we recommended the need for a multidisciplinary group to come together to determine what is the best approach. In an ideal world, this [approach] would be universal throughout the country.”

Although a revised UDDA would provide greater clarity to physicians and promote uniformity of practice, it would not resolve ongoing theological and philosophical debates about whether brain death is biological death, Dr. Pope said. “The key thing is that it would give clinicians a green light or certainty and clarity that they may proceed to do the test in the first place. If the tests are positive and the patient really is dead, then they could proceed to organ procurement or to move to the morgue.”

Dr. Lewis is a member of various AAN committees and working groups but receives no compensation for her role. A coauthor received personal fees from the AAN that were unrelated to the editorial.

[email protected]

SOURCE: Lewis A et al. Ann Intern Med. 2019 Dec 24. doi: 10.7326/M19-2731.