Pulmonology

The monoclonal antibody omalizumab, already approved to treat allergic asthma and urticaria, has been shown to improve symptoms of patients who have chronic rhinosinusitis and nasal polyps (CRSwNP), according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“When you give this drug to patients who have nasal polyposis and concomitant asthma, you are effectively treating both the upper and lower airway disease components,” Jonathan Corren, MD, of the University of California, Los Angeles, said in an interview. “Typically, people with nasal polyp disease have worse nasal disease than people without asthma. In addition, asthma is also generally worse in patients with nasal polyposis,” he added.

Dr. Corren reported results of a subset of patients with corticosteroid-refractory CRSwNP and comorbid asthma enrolled in phase III, placebo-controlled, 24-week, trials of omalizumab, POLYP1 (n = 74) and POLYP2 (n = 77). The analysis excluded patients who were on oral steroids or high-dose steroid inhaler therapy so the effectiveness of omalizumab could be evaluated without interfering factors, Dr. Corren explained. As a result, the study population consisted of patients with mild to moderate asthma. Dr. Corren is also principal investigator of the POLYP1 trial.

The analysis compared changes in Asthma Quality of Life Questionnaire (AQLQ) and sino-nasal outcome test (SNOT-22) measures after 24 weeks of treatment with those seen with placebo.

“With regard to asthma outcomes, we found there was a significant increase in the odds ratio that patients who received omalizumab would achieve a minimal, clinically important improvement in their asthma quality of life,” Dr. Corren said .

The study estimated the odds ratio for minimal clinically important difference in AQLQ at 24 weeks was 3.9 (95% confidence interval, 1.5-9.7; P = .0043), which Dr. Corren called “quite significant.” SNOT-22 scores showed a mean improvement of 23.3 from baseline to week 24, compared with a worsening of 8.4 in placebo (P = .0001).

Omalizumab is approved for treatment of perennial allergies and urticaria. Chronic rhinosinusitis with nasal polyps would be a third indication if the Food and Drug Administration approves it, Dr. Corren noted.

Genentech sponsored the subset analysis. Hoffmann-La Roche, Genentech’s parent company, is sponsor of the POLYP1 and POLYP2 trials. Dr. Corren disclosed financial relationships with Genentech.

SOURCE: Corren J et al. AAAAI, Session 4608, Abstract 813.

The monoclonal antibody omalizumab, already approved to treat allergic asthma and urticaria, has been shown to improve symptoms of patients who have chronic rhinosinusitis and nasal polyps (CRSwNP), according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“When you give this drug to patients who have nasal polyposis and concomitant asthma, you are effectively treating both the upper and lower airway disease components,” Jonathan Corren, MD, of the University of California, Los Angeles, said in an interview. “Typically, people with nasal polyp disease have worse nasal disease than people without asthma. In addition, asthma is also generally worse in patients with nasal polyposis,” he added.

Dr. Corren reported results of a subset of patients with corticosteroid-refractory CRSwNP and comorbid asthma enrolled in phase III, placebo-controlled, 24-week, trials of omalizumab, POLYP1 (n = 74) and POLYP2 (n = 77). The analysis excluded patients who were on oral steroids or high-dose steroid inhaler therapy so the effectiveness of omalizumab could be evaluated without interfering factors, Dr. Corren explained. As a result, the study population consisted of patients with mild to moderate asthma. Dr. Corren is also principal investigator of the POLYP1 trial.

The analysis compared changes in Asthma Quality of Life Questionnaire (AQLQ) and sino-nasal outcome test (SNOT-22) measures after 24 weeks of treatment with those seen with placebo.

“With regard to asthma outcomes, we found there was a significant increase in the odds ratio that patients who received omalizumab would achieve a minimal, clinically important improvement in their asthma quality of life,” Dr. Corren said .

The study estimated the odds ratio for minimal clinically important difference in AQLQ at 24 weeks was 3.9 (95% confidence interval, 1.5-9.7; P = .0043), which Dr. Corren called “quite significant.” SNOT-22 scores showed a mean improvement of 23.3 from baseline to week 24, compared with a worsening of 8.4 in placebo (P = .0001).

Omalizumab is approved for treatment of perennial allergies and urticaria. Chronic rhinosinusitis with nasal polyps would be a third indication if the Food and Drug Administration approves it, Dr. Corren noted.

Genentech sponsored the subset analysis. Hoffmann-La Roche, Genentech’s parent company, is sponsor of the POLYP1 and POLYP2 trials. Dr. Corren disclosed financial relationships with Genentech.

SOURCE: Corren J et al. AAAAI, Session 4608, Abstract 813.

The monoclonal antibody omalizumab, already approved to treat allergic asthma and urticaria, has been shown to improve symptoms of patients who have chronic rhinosinusitis and nasal polyps (CRSwNP), according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“When you give this drug to patients who have nasal polyposis and concomitant asthma, you are effectively treating both the upper and lower airway disease components,” Jonathan Corren, MD, of the University of California, Los Angeles, said in an interview. “Typically, people with nasal polyp disease have worse nasal disease than people without asthma. In addition, asthma is also generally worse in patients with nasal polyposis,” he added.

Dr. Corren reported results of a subset of patients with corticosteroid-refractory CRSwNP and comorbid asthma enrolled in phase III, placebo-controlled, 24-week, trials of omalizumab, POLYP1 (n = 74) and POLYP2 (n = 77). The analysis excluded patients who were on oral steroids or high-dose steroid inhaler therapy so the effectiveness of omalizumab could be evaluated without interfering factors, Dr. Corren explained. As a result, the study population consisted of patients with mild to moderate asthma. Dr. Corren is also principal investigator of the POLYP1 trial.

The analysis compared changes in Asthma Quality of Life Questionnaire (AQLQ) and sino-nasal outcome test (SNOT-22) measures after 24 weeks of treatment with those seen with placebo.

“With regard to asthma outcomes, we found there was a significant increase in the odds ratio that patients who received omalizumab would achieve a minimal, clinically important improvement in their asthma quality of life,” Dr. Corren said .

The study estimated the odds ratio for minimal clinically important difference in AQLQ at 24 weeks was 3.9 (95% confidence interval, 1.5-9.7; P = .0043), which Dr. Corren called “quite significant.” SNOT-22 scores showed a mean improvement of 23.3 from baseline to week 24, compared with a worsening of 8.4 in placebo (P = .0001).

Omalizumab is approved for treatment of perennial allergies and urticaria. Chronic rhinosinusitis with nasal polyps would be a third indication if the Food and Drug Administration approves it, Dr. Corren noted.

Genentech sponsored the subset analysis. Hoffmann-La Roche, Genentech’s parent company, is sponsor of the POLYP1 and POLYP2 trials. Dr. Corren disclosed financial relationships with Genentech.

SOURCE: Corren J et al. AAAAI, Session 4608, Abstract 813.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

The 2019-2020 flu season is ending, but not without a revised map to reflect the COVID-induced new world order.

[email protected]

The 2019-2020 flu season is ending, but not without a revised map to reflect the COVID-induced new world order.

[email protected]

The 2019-2020 flu season is ending, but not without a revised map to reflect the COVID-induced new world order.

[email protected]

This month, I would like to touch on a few COVID-19 topics that have received much publicity, with some messages about them having been confusing.

Let’s start with a case:

A 37-year-old woman is seen in clinic for a 5-day history of cough, fever, chest tightness, and onset of dyspnea on the day of her office visit.

An exam reveals her blood pressure is 100/60 mm Hg, her pulse is 100 beats per minute, her temperature is 38.7° C, her oxygen saturation is 93%, and her respiratory rate is 20 breaths per minute.

Auscultation of the chest revealed bilateral wheezing and rhonchi. A nasopharyngeal swab is sent for COVID-19 and is negative; she also tests negative for influenza.

Her hemoglobin level is 13 g/dL, hematocrit was 39%, platelet count was 155,000 per mcL of blood, and D-dimer level was 8.4 mcg/mL (normal is less than 0.4 mcg/mL.) Her white blood cell count was 6,000 per mcL of blood (neutrophils, 4,900; lymphocytes, 800; basophils, 200). Her chest x-ray showed bilateral lower lobe infiltrates.
 

What do you recommend?

A. Begin azithromycin plus ceftriaxone

B. Begin azithromycin

C. Begin oseltamivir

D. Obtain chest CT

E. Repeat COVID-19 test

With the massive amount of information coming out every day on COVID-19, it is hard to keep up with all of it, and sort out accurate, reviewed studies. We are in a position where we need to take in what we can and assess the best data available.

In the case above, I think choices D or E would make sense. This patient very likely has COVID-19 based on clinical symptoms and lab parameters. The negative COVID-19 test gives us pause, but several studies show that false negative tests are not uncommon.

Long et al. reported on 36 patients who had received both chest CT and real-time reverse transcription polymerase chain reaction (rRT-PCR) for COVID-19.¹ All were eventually diagnosed with COVID-19 pneumonia. The CT scan had a very high sensitivity (35/36) of 97.2%, whereas the rRT-PCR had a lower sensitivity (30/36) of 83%. All six of the patients with a negative COVID-19 test initially were positive on repeat testing (three on the second test, three on the third test).

There are concerns about what the sensitivity of the rRT-PCR tests being run in the United States are. At this point, I think that, when the pretest probability of COVID-19 infection is very high based on local epidemiology and clinical symptoms, a negative COVID rRT-PCR does not eliminate the diagnosis. In many cases, COVID-19 may still be the most likely diagnosis.

Early in the pandemic, the symptoms that were emphasized were fever, cough, and dyspnea. Those were all crucial symptoms for a disease that causes pneumonia. GI symptoms were initially deemphasized. In an early study released from Wuhan, China, only about 5% of COVID-19 patients had nausea or diarrhea.² In a study of 305 patients focused on gastrointestinal symptoms, half of the patients had diarrhea, half had anorexia and 30% had nausea.³ In a small series of nine patients who presented with only GI symptoms, four of these patients never developed fever or pulmonary symptoms.³

On March 14, the French health minister, Olivier Véran, tweeted that “taking anti-inflammatory drugs (ibuprofen, cortisone ...) could be an aggravating factor for the infection. If you have a fever, take paracetamol.” This was picked up by many news services, and soon became standard recommendations, despite no data.

There is reason for concern for NSAIDs, as regular NSAID use has been tied to more complications in patients with respiratory tract infections.⁴ I have never been a proponent of regular NSAID use in patients who are infected, because the likelihood of toxicity is elevated in patients who are volume depleted or under physiologic stress. But at this time, there is no evidence on problems with episodic NSAID use in patients with COVID-19.

Another widely disseminated decree was that patients with COVID-19 should not use ACE inhibitors and angiotensin II receptor blockers (ARBs). COVID-19 binds to their target cells through ACE2, which is expressed by epithelial cells of the lung, intestine and kidney. Patients who are treated with ACE inhibitors and ARBs have been shown to have more ACE2 expression.

In a letter to the editor by Fang et al. published in Lancet Respiratory Medicine, the authors raised the question of whether patients might be better served to be switched from ACE inhibitors and ARBs to calcium-channel blockers for the treatment of hypertension.⁵ A small study by Meng et al. looked at outcomes of patients on these drugs who had COVID-19 infection.⁶ They looked at 417 patients admitted to a hospital in China with COVID-19 infection. A total of 42 patients were on medications for hypertension. Group 1 were patients on ACE inhibitors/ARBs (17 patients) and group 2 were patients on other antihypertensives (25 patients). During hospitalization 12 patients (48%) in group 2 were categorized as having severe disease and 1 patient died. In group 1 (the ACE inhibitor/ARB–treated patients) only four (23%) were categorized as having severe disease, and no patients in this group died.

Vaduganathan et al. published a special report in the New England Journal of Medicine strongly arguing the point that “[u]ntil further data are available, we think that [renin-angiotensin-aldosterone system] inhibitors should be continued in patients in otherwise stable condition who are at risk for, being evaluated for, or with COVID-19”.⁷ This position is supported by the American Heart Association, the American College of Cardiology, the American College of Physicians, and 11 other medical organizations.
 

Take-home messages

• Testing isn’t perfect – if you have strong suspicion for COVID-19 disease, retest.
• GI symptoms appear to be common, and rarely may be the only symptoms initially.
• NSAIDs are always risky in really sick patients, but data specific to COVID-19 is lacking.
• ACE inhibitors/ARBs should not be avoided in patients with COVID-19.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at [email protected].

References

1. Long C et al. Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Eur J Radiol. 2020 Mar 25;126:108961.

2. Zhou F et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-62.

3. Tian Y et al. Review article: Gastrointestinal features in COVID-19 and the possibility of faecal transmission. Aliment Pharmacol Ther. 2020;00:1–9.

4. Voiriot G et al. Risks related to the use of nonsteroidal anti-inflammatory drugs in community-acquired pneumonia in adult and pediatric patients. J Clin Med. 2019;8:E786.

5. Fang L et al. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020 Mar 11. doi:10.1016/S2213-2600(20)30116-8.

6. Meng J et al. Renin-angiotensin system inhibitors improve the clinical outcomes of COVID-19 patients with hypertension. Renin-angiotensin system inhibitors improve the clinical outcomes of COVID-19 patients with hypertension. Emerg Microbes Infect. 2020 Dec;9(1):757-60.

7. Vaduganathan M et al. Renin-angiotensin-aldosterone system inhibitors in patients with COVID-19. N Engl J Med. 2020 Mar 30. doi: 10.1056/NEJMsr2005760.

This month, I would like to touch on a few COVID-19 topics that have received much publicity, with some messages about them having been confusing.

Let’s start with a case:

A 37-year-old woman is seen in clinic for a 5-day history of cough, fever, chest tightness, and onset of dyspnea on the day of her office visit.

An exam reveals her blood pressure is 100/60 mm Hg, her pulse is 100 beats per minute, her temperature is 38.7° C, her oxygen saturation is 93%, and her respiratory rate is 20 breaths per minute.

Auscultation of the chest revealed bilateral wheezing and rhonchi. A nasopharyngeal swab is sent for COVID-19 and is negative; she also tests negative for influenza.

Her hemoglobin level is 13 g/dL, hematocrit was 39%, platelet count was 155,000 per mcL of blood, and D-dimer level was 8.4 mcg/mL (normal is less than 0.4 mcg/mL.) Her white blood cell count was 6,000 per mcL of blood (neutrophils, 4,900; lymphocytes, 800; basophils, 200). Her chest x-ray showed bilateral lower lobe infiltrates.
 

What do you recommend?

A. Begin azithromycin plus ceftriaxone

B. Begin azithromycin

C. Begin oseltamivir

D. Obtain chest CT

E. Repeat COVID-19 test

With the massive amount of information coming out every day on COVID-19, it is hard to keep up with all of it, and sort out accurate, reviewed studies. We are in a position where we need to take in what we can and assess the best data available.

In the case above, I think choices D or E would make sense. This patient very likely has COVID-19 based on clinical symptoms and lab parameters. The negative COVID-19 test gives us pause, but several studies show that false negative tests are not uncommon.

Long et al. reported on 36 patients who had received both chest CT and real-time reverse transcription polymerase chain reaction (rRT-PCR) for COVID-19.¹ All were eventually diagnosed with COVID-19 pneumonia. The CT scan had a very high sensitivity (35/36) of 97.2%, whereas the rRT-PCR had a lower sensitivity (30/36) of 83%. All six of the patients with a negative COVID-19 test initially were positive on repeat testing (three on the second test, three on the third test).

There are concerns about what the sensitivity of the rRT-PCR tests being run in the United States are. At this point, I think that, when the pretest probability of COVID-19 infection is very high based on local epidemiology and clinical symptoms, a negative COVID rRT-PCR does not eliminate the diagnosis. In many cases, COVID-19 may still be the most likely diagnosis.

Early in the pandemic, the symptoms that were emphasized were fever, cough, and dyspnea. Those were all crucial symptoms for a disease that causes pneumonia. GI symptoms were initially deemphasized. In an early study released from Wuhan, China, only about 5% of COVID-19 patients had nausea or diarrhea.² In a study of 305 patients focused on gastrointestinal symptoms, half of the patients had diarrhea, half had anorexia and 30% had nausea.³ In a small series of nine patients who presented with only GI symptoms, four of these patients never developed fever or pulmonary symptoms.³

On March 14, the French health minister, Olivier Véran, tweeted that “taking anti-inflammatory drugs (ibuprofen, cortisone ...) could be an aggravating factor for the infection. If you have a fever, take paracetamol.” This was picked up by many news services, and soon became standard recommendations, despite no data.

There is reason for concern for NSAIDs, as regular NSAID use has been tied to more complications in patients with respiratory tract infections.⁴ I have never been a proponent of regular NSAID use in patients who are infected, because the likelihood of toxicity is elevated in patients who are volume depleted or under physiologic stress. But at this time, there is no evidence on problems with episodic NSAID use in patients with COVID-19.

Another widely disseminated decree was that patients with COVID-19 should not use ACE inhibitors and angiotensin II receptor blockers (ARBs). COVID-19 binds to their target cells through ACE2, which is expressed by epithelial cells of the lung, intestine and kidney. Patients who are treated with ACE inhibitors and ARBs have been shown to have more ACE2 expression.

In a letter to the editor by Fang et al. published in Lancet Respiratory Medicine, the authors raised the question of whether patients might be better served to be switched from ACE inhibitors and ARBs to calcium-channel blockers for the treatment of hypertension.⁵ A small study by Meng et al. looked at outcomes of patients on these drugs who had COVID-19 infection.⁶ They looked at 417 patients admitted to a hospital in China with COVID-19 infection. A total of 42 patients were on medications for hypertension. Group 1 were patients on ACE inhibitors/ARBs (17 patients) and group 2 were patients on other antihypertensives (25 patients). During hospitalization 12 patients (48%) in group 2 were categorized as having severe disease and 1 patient died. In group 1 (the ACE inhibitor/ARB–treated patients) only four (23%) were categorized as having severe disease, and no patients in this group died.

Vaduganathan et al. published a special report in the New England Journal of Medicine strongly arguing the point that “[u]ntil further data are available, we think that [renin-angiotensin-aldosterone system] inhibitors should be continued in patients in otherwise stable condition who are at risk for, being evaluated for, or with COVID-19”.⁷ This position is supported by the American Heart Association, the American College of Cardiology, the American College of Physicians, and 11 other medical organizations.
 

Take-home messages

• Testing isn’t perfect – if you have strong suspicion for COVID-19 disease, retest.
• GI symptoms appear to be common, and rarely may be the only symptoms initially.
• NSAIDs are always risky in really sick patients, but data specific to COVID-19 is lacking.
• ACE inhibitors/ARBs should not be avoided in patients with COVID-19.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at [email protected].

References

1. Long C et al. Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Eur J Radiol. 2020 Mar 25;126:108961.

2. Zhou F et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-62.

3. Tian Y et al. Review article: Gastrointestinal features in COVID-19 and the possibility of faecal transmission. Aliment Pharmacol Ther. 2020;00:1–9.

4. Voiriot G et al. Risks related to the use of nonsteroidal anti-inflammatory drugs in community-acquired pneumonia in adult and pediatric patients. J Clin Med. 2019;8:E786.

5. Fang L et al. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020 Mar 11. doi:10.1016/S2213-2600(20)30116-8.

6. Meng J et al. Renin-angiotensin system inhibitors improve the clinical outcomes of COVID-19 patients with hypertension. Renin-angiotensin system inhibitors improve the clinical outcomes of COVID-19 patients with hypertension. Emerg Microbes Infect. 2020 Dec;9(1):757-60.

7. Vaduganathan M et al. Renin-angiotensin-aldosterone system inhibitors in patients with COVID-19. N Engl J Med. 2020 Mar 30. doi: 10.1056/NEJMsr2005760.

This month, I would like to touch on a few COVID-19 topics that have received much publicity, with some messages about them having been confusing.

Let’s start with a case:

A 37-year-old woman is seen in clinic for a 5-day history of cough, fever, chest tightness, and onset of dyspnea on the day of her office visit.

An exam reveals her blood pressure is 100/60 mm Hg, her pulse is 100 beats per minute, her temperature is 38.7° C, her oxygen saturation is 93%, and her respiratory rate is 20 breaths per minute.

Auscultation of the chest revealed bilateral wheezing and rhonchi. A nasopharyngeal swab is sent for COVID-19 and is negative; she also tests negative for influenza.

Her hemoglobin level is 13 g/dL, hematocrit was 39%, platelet count was 155,000 per mcL of blood, and D-dimer level was 8.4 mcg/mL (normal is less than 0.4 mcg/mL.) Her white blood cell count was 6,000 per mcL of blood (neutrophils, 4,900; lymphocytes, 800; basophils, 200). Her chest x-ray showed bilateral lower lobe infiltrates.
 

What do you recommend?

A. Begin azithromycin plus ceftriaxone

B. Begin azithromycin

C. Begin oseltamivir

D. Obtain chest CT

E. Repeat COVID-19 test

With the massive amount of information coming out every day on COVID-19, it is hard to keep up with all of it, and sort out accurate, reviewed studies. We are in a position where we need to take in what we can and assess the best data available.

In the case above, I think choices D or E would make sense. This patient very likely has COVID-19 based on clinical symptoms and lab parameters. The negative COVID-19 test gives us pause, but several studies show that false negative tests are not uncommon.

Long et al. reported on 36 patients who had received both chest CT and real-time reverse transcription polymerase chain reaction (rRT-PCR) for COVID-19.¹ All were eventually diagnosed with COVID-19 pneumonia. The CT scan had a very high sensitivity (35/36) of 97.2%, whereas the rRT-PCR had a lower sensitivity (30/36) of 83%. All six of the patients with a negative COVID-19 test initially were positive on repeat testing (three on the second test, three on the third test).

There are concerns about what the sensitivity of the rRT-PCR tests being run in the United States are. At this point, I think that, when the pretest probability of COVID-19 infection is very high based on local epidemiology and clinical symptoms, a negative COVID rRT-PCR does not eliminate the diagnosis. In many cases, COVID-19 may still be the most likely diagnosis.

Early in the pandemic, the symptoms that were emphasized were fever, cough, and dyspnea. Those were all crucial symptoms for a disease that causes pneumonia. GI symptoms were initially deemphasized. In an early study released from Wuhan, China, only about 5% of COVID-19 patients had nausea or diarrhea.² In a study of 305 patients focused on gastrointestinal symptoms, half of the patients had diarrhea, half had anorexia and 30% had nausea.³ In a small series of nine patients who presented with only GI symptoms, four of these patients never developed fever or pulmonary symptoms.³

On March 14, the French health minister, Olivier Véran, tweeted that “taking anti-inflammatory drugs (ibuprofen, cortisone ...) could be an aggravating factor for the infection. If you have a fever, take paracetamol.” This was picked up by many news services, and soon became standard recommendations, despite no data.

There is reason for concern for NSAIDs, as regular NSAID use has been tied to more complications in patients with respiratory tract infections.⁴ I have never been a proponent of regular NSAID use in patients who are infected, because the likelihood of toxicity is elevated in patients who are volume depleted or under physiologic stress. But at this time, there is no evidence on problems with episodic NSAID use in patients with COVID-19.

Another widely disseminated decree was that patients with COVID-19 should not use ACE inhibitors and angiotensin II receptor blockers (ARBs). COVID-19 binds to their target cells through ACE2, which is expressed by epithelial cells of the lung, intestine and kidney. Patients who are treated with ACE inhibitors and ARBs have been shown to have more ACE2 expression.

In a letter to the editor by Fang et al. published in Lancet Respiratory Medicine, the authors raised the question of whether patients might be better served to be switched from ACE inhibitors and ARBs to calcium-channel blockers for the treatment of hypertension.⁵ A small study by Meng et al. looked at outcomes of patients on these drugs who had COVID-19 infection.⁶ They looked at 417 patients admitted to a hospital in China with COVID-19 infection. A total of 42 patients were on medications for hypertension. Group 1 were patients on ACE inhibitors/ARBs (17 patients) and group 2 were patients on other antihypertensives (25 patients). During hospitalization 12 patients (48%) in group 2 were categorized as having severe disease and 1 patient died. In group 1 (the ACE inhibitor/ARB–treated patients) only four (23%) were categorized as having severe disease, and no patients in this group died.

Vaduganathan et al. published a special report in the New England Journal of Medicine strongly arguing the point that “[u]ntil further data are available, we think that [renin-angiotensin-aldosterone system] inhibitors should be continued in patients in otherwise stable condition who are at risk for, being evaluated for, or with COVID-19”.⁷ This position is supported by the American Heart Association, the American College of Cardiology, the American College of Physicians, and 11 other medical organizations.
 

Take-home messages

• Testing isn’t perfect – if you have strong suspicion for COVID-19 disease, retest.
• GI symptoms appear to be common, and rarely may be the only symptoms initially.
• NSAIDs are always risky in really sick patients, but data specific to COVID-19 is lacking.
• ACE inhibitors/ARBs should not be avoided in patients with COVID-19.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at [email protected].

References

1. Long C et al. Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Eur J Radiol. 2020 Mar 25;126:108961.

2. Zhou F et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-62.

3. Tian Y et al. Review article: Gastrointestinal features in COVID-19 and the possibility of faecal transmission. Aliment Pharmacol Ther. 2020;00:1–9.

4. Voiriot G et al. Risks related to the use of nonsteroidal anti-inflammatory drugs in community-acquired pneumonia in adult and pediatric patients. J Clin Med. 2019;8:E786.

5. Fang L et al. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020 Mar 11. doi:10.1016/S2213-2600(20)30116-8.

6. Meng J et al. Renin-angiotensin system inhibitors improve the clinical outcomes of COVID-19 patients with hypertension. Renin-angiotensin system inhibitors improve the clinical outcomes of COVID-19 patients with hypertension. Emerg Microbes Infect. 2020 Dec;9(1):757-60.

7. Vaduganathan M et al. Renin-angiotensin-aldosterone system inhibitors in patients with COVID-19. N Engl J Med. 2020 Mar 30. doi: 10.1056/NEJMsr2005760.

Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.

xrender/Thinkstock

However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In her presentation, Alana T. Brennan, PhD, of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.

A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.

Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.

“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.

Dr. Brennan reported that there were no disclosures.

[email protected]

SOURCE: Brennan AT et al. CROI 2020, Abstract 720.

Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.

xrender/Thinkstock

However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In her presentation, Alana T. Brennan, PhD, of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.

A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.

Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.

“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.

Dr. Brennan reported that there were no disclosures.

[email protected]

SOURCE: Brennan AT et al. CROI 2020, Abstract 720.

Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.

xrender/Thinkstock

However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In her presentation, Alana T. Brennan, PhD, of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.

A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.

Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.

“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.

Dr. Brennan reported that there were no disclosures.

[email protected]

SOURCE: Brennan AT et al. CROI 2020, Abstract 720.

Among patients admitted to a hospital with chronic obstructive pulmonary disease (COPD) exacerbation, obstructive sleep apnea (OSA) is prevalent and increases the likelihood of hospital readmission more than threefold, according to results from a single-center study published in CHEST.

Mario Naranjo, MD, and colleagues retrospectively examined data from Albert Einstein Medical Center in Philadelphia to assess the impact of OSA on hospital readmission within 30 days of discharge after treatment for a COPD exacerbation. Dr. Naranjo is affiliated with Johns Hopkins Medicine, Baltimore.

The researchers analyzed data from 238 patients admitted for COPD exacerbation between May 2017 and July 2018 who were screened for previously unrecognized and untreated OSA and underwent a high-resolution pulse-oximetry or portable sleep monitoring study. In all, 111 (46.6%) had OSA; 28.6% had mild OSA, 9.7% had moderate OSA, and 8.4% had severe OSA.

Most baseline characteristics were similar among patients with and without OSA, but patients with OSA had a greater mean body mass index (33.9 vs. 30.3 kg/m²) and were more likely to have comorbid heart failure (19.8% vs. 7.1%), compared with patients without OSA. In addition, the proportion of male patients was greater in the cohort with OSA (60.4% vs. 49.6%).

For patients with mild OSA (oxygen desaturation index [ODI] ≥ 5 and < 15/hour), the odds of 30-day readmission were 2.05 times higher, compared with patients without OSA (32.4% vs. 18.9%). With moderate OSA (ODI ≥ 15 and < 30/hour), the odds of 30-day readmission were 6.68 times higher (60.9% vs. 18.9%). For severe OSA (ODI ≥ 30/hour), the odds were 10.01 times higher (70.0% vs. 18.9%). “For combined OSA severity categories, the odds of 30-day readmission were 3.5 times higher,” said Dr. Naranjo and colleagues. In addition, 90- and 180-day readmission rates and 6-month mortality rates were higher among patients with OSA.

“These findings have important implications for the evaluation and care of patients admitted to the hospital for COPD exacerbations,” Dr. Naranjo and colleagues said. “Although the combination of COPD and OSA (also known as the “overlap syndrome”) in ambulatory settings has been shown to have worse outcomes in terms of COPD exacerbations and mortality, these findings have not been reported previously for hospitalized COPD patients.”

Greater degrees of nocturnal hypoxemia and hypercapnia, worse functional status, and daytime sleepiness and fatigue may contribute to the relationship between OSA and the likelihood of hospital readmission, according to the authors. A multicenter study is warranted to confirm the results, they said.

Dr. Naranjo had no conflicts of interest. Coauthors have received grants from ResMed, Dayzz, and the National Institutes of Health and consulted for Jazz Pharmaceuticals, Best Doctors, and ResMed. One author is a committee chair for the American Academy of Sleep Medicine.

[email protected]

SOURCE: Naranjo M et al. Chest. 2020 Apr 2. doi: 10.1016/j.chest.2020.03.036.

Among patients admitted to a hospital with chronic obstructive pulmonary disease (COPD) exacerbation, obstructive sleep apnea (OSA) is prevalent and increases the likelihood of hospital readmission more than threefold, according to results from a single-center study published in CHEST.

Mario Naranjo, MD, and colleagues retrospectively examined data from Albert Einstein Medical Center in Philadelphia to assess the impact of OSA on hospital readmission within 30 days of discharge after treatment for a COPD exacerbation. Dr. Naranjo is affiliated with Johns Hopkins Medicine, Baltimore.

The researchers analyzed data from 238 patients admitted for COPD exacerbation between May 2017 and July 2018 who were screened for previously unrecognized and untreated OSA and underwent a high-resolution pulse-oximetry or portable sleep monitoring study. In all, 111 (46.6%) had OSA; 28.6% had mild OSA, 9.7% had moderate OSA, and 8.4% had severe OSA.

Most baseline characteristics were similar among patients with and without OSA, but patients with OSA had a greater mean body mass index (33.9 vs. 30.3 kg/m²) and were more likely to have comorbid heart failure (19.8% vs. 7.1%), compared with patients without OSA. In addition, the proportion of male patients was greater in the cohort with OSA (60.4% vs. 49.6%).

For patients with mild OSA (oxygen desaturation index [ODI] ≥ 5 and < 15/hour), the odds of 30-day readmission were 2.05 times higher, compared with patients without OSA (32.4% vs. 18.9%). With moderate OSA (ODI ≥ 15 and < 30/hour), the odds of 30-day readmission were 6.68 times higher (60.9% vs. 18.9%). For severe OSA (ODI ≥ 30/hour), the odds were 10.01 times higher (70.0% vs. 18.9%). “For combined OSA severity categories, the odds of 30-day readmission were 3.5 times higher,” said Dr. Naranjo and colleagues. In addition, 90- and 180-day readmission rates and 6-month mortality rates were higher among patients with OSA.

“These findings have important implications for the evaluation and care of patients admitted to the hospital for COPD exacerbations,” Dr. Naranjo and colleagues said. “Although the combination of COPD and OSA (also known as the “overlap syndrome”) in ambulatory settings has been shown to have worse outcomes in terms of COPD exacerbations and mortality, these findings have not been reported previously for hospitalized COPD patients.”

Greater degrees of nocturnal hypoxemia and hypercapnia, worse functional status, and daytime sleepiness and fatigue may contribute to the relationship between OSA and the likelihood of hospital readmission, according to the authors. A multicenter study is warranted to confirm the results, they said.

Dr. Naranjo had no conflicts of interest. Coauthors have received grants from ResMed, Dayzz, and the National Institutes of Health and consulted for Jazz Pharmaceuticals, Best Doctors, and ResMed. One author is a committee chair for the American Academy of Sleep Medicine.

[email protected]

SOURCE: Naranjo M et al. Chest. 2020 Apr 2. doi: 10.1016/j.chest.2020.03.036.

Among patients admitted to a hospital with chronic obstructive pulmonary disease (COPD) exacerbation, obstructive sleep apnea (OSA) is prevalent and increases the likelihood of hospital readmission more than threefold, according to results from a single-center study published in CHEST.

Mario Naranjo, MD, and colleagues retrospectively examined data from Albert Einstein Medical Center in Philadelphia to assess the impact of OSA on hospital readmission within 30 days of discharge after treatment for a COPD exacerbation. Dr. Naranjo is affiliated with Johns Hopkins Medicine, Baltimore.

The researchers analyzed data from 238 patients admitted for COPD exacerbation between May 2017 and July 2018 who were screened for previously unrecognized and untreated OSA and underwent a high-resolution pulse-oximetry or portable sleep monitoring study. In all, 111 (46.6%) had OSA; 28.6% had mild OSA, 9.7% had moderate OSA, and 8.4% had severe OSA.

Most baseline characteristics were similar among patients with and without OSA, but patients with OSA had a greater mean body mass index (33.9 vs. 30.3 kg/m²) and were more likely to have comorbid heart failure (19.8% vs. 7.1%), compared with patients without OSA. In addition, the proportion of male patients was greater in the cohort with OSA (60.4% vs. 49.6%).

For patients with mild OSA (oxygen desaturation index [ODI] ≥ 5 and < 15/hour), the odds of 30-day readmission were 2.05 times higher, compared with patients without OSA (32.4% vs. 18.9%). With moderate OSA (ODI ≥ 15 and < 30/hour), the odds of 30-day readmission were 6.68 times higher (60.9% vs. 18.9%). For severe OSA (ODI ≥ 30/hour), the odds were 10.01 times higher (70.0% vs. 18.9%). “For combined OSA severity categories, the odds of 30-day readmission were 3.5 times higher,” said Dr. Naranjo and colleagues. In addition, 90- and 180-day readmission rates and 6-month mortality rates were higher among patients with OSA.

“These findings have important implications for the evaluation and care of patients admitted to the hospital for COPD exacerbations,” Dr. Naranjo and colleagues said. “Although the combination of COPD and OSA (also known as the “overlap syndrome”) in ambulatory settings has been shown to have worse outcomes in terms of COPD exacerbations and mortality, these findings have not been reported previously for hospitalized COPD patients.”

Greater degrees of nocturnal hypoxemia and hypercapnia, worse functional status, and daytime sleepiness and fatigue may contribute to the relationship between OSA and the likelihood of hospital readmission, according to the authors. A multicenter study is warranted to confirm the results, they said.

Dr. Naranjo had no conflicts of interest. Coauthors have received grants from ResMed, Dayzz, and the National Institutes of Health and consulted for Jazz Pharmaceuticals, Best Doctors, and ResMed. One author is a committee chair for the American Academy of Sleep Medicine.

[email protected]

SOURCE: Naranjo M et al. Chest. 2020 Apr 2. doi: 10.1016/j.chest.2020.03.036.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The Food and Drug Administration has approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation, according to a release from the agency. This inhaler is indicated for prevention of bronchospasm in patients aged 4 years and older. Specifically, these are patients with reversible obstructive airway disease or exercise-induced bronchospasm.

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD.

The most common side effects include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.

This approval comes as part of FDA’s efforts to guide industry through the development process of generic products, according to the release. Complex combination products – such as this inhaler, which comprises both medication and a delivery system – can be more challenging to develop than solid oral dosage forms, such as tablets.

The FDA released a draft guidance in March 2020 specific to proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. As with other similar guidances, it details the steps companies need to take in developing generics in order to submit complete applications for those products. The full news release regarding this approval is available on the FDA website.

[email protected]

This article was updated 4/8/20.

The Food and Drug Administration has approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation, according to a release from the agency. This inhaler is indicated for prevention of bronchospasm in patients aged 4 years and older. Specifically, these are patients with reversible obstructive airway disease or exercise-induced bronchospasm.

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD.

The most common side effects include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.

This approval comes as part of FDA’s efforts to guide industry through the development process of generic products, according to the release. Complex combination products – such as this inhaler, which comprises both medication and a delivery system – can be more challenging to develop than solid oral dosage forms, such as tablets.

The FDA released a draft guidance in March 2020 specific to proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. As with other similar guidances, it details the steps companies need to take in developing generics in order to submit complete applications for those products. The full news release regarding this approval is available on the FDA website.

[email protected]

This article was updated 4/8/20.

The Food and Drug Administration has approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation, according to a release from the agency. This inhaler is indicated for prevention of bronchospasm in patients aged 4 years and older. Specifically, these are patients with reversible obstructive airway disease or exercise-induced bronchospasm.

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD.

The most common side effects include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.

This approval comes as part of FDA’s efforts to guide industry through the development process of generic products, according to the release. Complex combination products – such as this inhaler, which comprises both medication and a delivery system – can be more challenging to develop than solid oral dosage forms, such as tablets.

The FDA released a draft guidance in March 2020 specific to proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. As with other similar guidances, it details the steps companies need to take in developing generics in order to submit complete applications for those products. The full news release regarding this approval is available on the FDA website.

[email protected]

This article was updated 4/8/20.