Society of Critical Care Medicine (SCCM): Critical Care Congress

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Noninvasive ventilation safe in general, but not for CAP

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Noninvasive ventilation safe in general, but not for CAP

SAN JUAN, P.R.  – Noninvasive ventilation can be safely initiated and monitored on a general medical ward, taking some of the pressure off intensive care units, investigators reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

A retrospective study comparing outcomes for patients started on noninvasive ventilation (NIV) on general floors with those of patients put on NIV in the ICU showed that patients on the general wards were less likely to need intubation and had a shorter length of stay, but with mortality similar to that of ICU-treated patients, reported Dr. Edison Gavilanes, a resident in internal medicine at New York Hospital Queens.

If the patients started on noninvasive ventilation have community-acquired pneumonia (CAP), however, there is a high likelihood that they will eventually need to be intubated, cautioned Dr. Anwar Murad, an internal medicine resident at McGill University Health Centre, Montreal.

"Even though current evidence does not support NIV use in CAP, our data demonstrate that it is commonly employed in critical care units," Dr. Murad said in a poster presentation.

NIV in general

The New York researchers noted that, although current guidelines recommend that patients be started on NIV in the ICU and transferred to a step-down unit when they are stable, there are "little data to suggest that NIV on general wards is unsafe or that it could have an effect on mortality."

To see whether it was safe to start patients on NIV in general wards, they took a retrospective look at the records of 647 patients treated with NIV in 2011, collecting both clinical and demographic parameters as well as physiologic measures, including pH levels, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), and serum bicarbonate.

They found that, compared with the 184 patients in whom NIV was initiated in the ICU, the group of 463 patients started on NIV on the general wards had a higher mean age (77.8 vs. 73.1 years), more females than males (56.6% vs. 41.8%), higher mean pCO2 (51.4 vs. 42.9 mm Hg; P less than .0001), and was more likely to have respiratory failure from pulmonary causes rather than heart failure (69.8% vs. 51.1%; P less than .007).

Patients in the general wards had a significantly lower incidence of intubation (14.5% vs. 47.3%; P less than .0001) and shorter length of stay (11.6 vs. 15.9 days; P = .0001), Dr. Gavilanes reported.

There was no significant difference in mortality.

Variables associated with failure of an NIV trial on the floor and transfer to the ICU included the presence of metabolic acidosis, vasopressor requirement, and need for intubation. Patients who required transfer to the ICU had a higher mortality rate than did those who did not require it (62.9% vs. 27.6%; P less than .0001).

The investigators noted that "93% of the patients in whom NIV was started on the general medical wards did not require eventual ICU transfer or have increased mortality. However, patients with hemodynamic instability and metabolic acidosis can fail NIV and might benefit from ICU level monitoring."

NIV common for CAP

The Canadian researchers examined whether NIV was safe in patients with community-acquired pneumonia.

"Despite a lack of data supporting its use, NIV is commonly used in the management of patients with CAP. It is unclear which patients benefit from NIV and avoid endotracheal intubation," Dr. Murad said.

He and his associates conducted a retrospective cohort study of records on patients admitted to three critical care units from 2007 to 2012 with a diagnosis of CAP who were started on either noninvasive or invasive ventilation.

They identified 229 patients – 93 were intubated and 136 were started on NIV. Patients on NIV tended to be older (median age, 73 vs. 68 years), but there were no significant differences in baseline characteristics.

There were no significant differences in mortality for the overall cohort (46% vs. 33%), cardiac care unit length of stay (9 days in each group), or hospital length of stay (20 days vs. 17 days).

However, 101 (74%) patients failed NIV and required endotracheal intubation. Of the 101 patients in the NIV failure group, 50 (49.5%) required vasopressors, compared with 4 of the 35 patients (11.4%) who were successfully maintained on NIV.

As in the study by Dr. Gavilanes and his colleagues, there were significantly more deaths among patients who failed NIV (53 vs. 8; P = .002), as well as hemodynamic instability (54 vs. 8; P less than .001), and lactic acidosis (31 vs. 2; P =.003).

 

 

"Patients with CAP treated with NIV have a high likelihood of requiring intubation and developing significant complications. Patients started on NIV for severe CAP should be considered for early intubation if found to require vasopressor or have persistent hypoxemia/acidosis," Dr. Murad said.

Both studies were internally funded. Dr. Gavilanes and Dr. Murad each reported having no financial disclosures.

[email protected]

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SAN JUAN, P.R.  – Noninvasive ventilation can be safely initiated and monitored on a general medical ward, taking some of the pressure off intensive care units, investigators reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

A retrospective study comparing outcomes for patients started on noninvasive ventilation (NIV) on general floors with those of patients put on NIV in the ICU showed that patients on the general wards were less likely to need intubation and had a shorter length of stay, but with mortality similar to that of ICU-treated patients, reported Dr. Edison Gavilanes, a resident in internal medicine at New York Hospital Queens.

If the patients started on noninvasive ventilation have community-acquired pneumonia (CAP), however, there is a high likelihood that they will eventually need to be intubated, cautioned Dr. Anwar Murad, an internal medicine resident at McGill University Health Centre, Montreal.

"Even though current evidence does not support NIV use in CAP, our data demonstrate that it is commonly employed in critical care units," Dr. Murad said in a poster presentation.

NIV in general

The New York researchers noted that, although current guidelines recommend that patients be started on NIV in the ICU and transferred to a step-down unit when they are stable, there are "little data to suggest that NIV on general wards is unsafe or that it could have an effect on mortality."

To see whether it was safe to start patients on NIV in general wards, they took a retrospective look at the records of 647 patients treated with NIV in 2011, collecting both clinical and demographic parameters as well as physiologic measures, including pH levels, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), and serum bicarbonate.

They found that, compared with the 184 patients in whom NIV was initiated in the ICU, the group of 463 patients started on NIV on the general wards had a higher mean age (77.8 vs. 73.1 years), more females than males (56.6% vs. 41.8%), higher mean pCO2 (51.4 vs. 42.9 mm Hg; P less than .0001), and was more likely to have respiratory failure from pulmonary causes rather than heart failure (69.8% vs. 51.1%; P less than .007).

Patients in the general wards had a significantly lower incidence of intubation (14.5% vs. 47.3%; P less than .0001) and shorter length of stay (11.6 vs. 15.9 days; P = .0001), Dr. Gavilanes reported.

There was no significant difference in mortality.

Variables associated with failure of an NIV trial on the floor and transfer to the ICU included the presence of metabolic acidosis, vasopressor requirement, and need for intubation. Patients who required transfer to the ICU had a higher mortality rate than did those who did not require it (62.9% vs. 27.6%; P less than .0001).

The investigators noted that "93% of the patients in whom NIV was started on the general medical wards did not require eventual ICU transfer or have increased mortality. However, patients with hemodynamic instability and metabolic acidosis can fail NIV and might benefit from ICU level monitoring."

NIV common for CAP

The Canadian researchers examined whether NIV was safe in patients with community-acquired pneumonia.

"Despite a lack of data supporting its use, NIV is commonly used in the management of patients with CAP. It is unclear which patients benefit from NIV and avoid endotracheal intubation," Dr. Murad said.

He and his associates conducted a retrospective cohort study of records on patients admitted to three critical care units from 2007 to 2012 with a diagnosis of CAP who were started on either noninvasive or invasive ventilation.

They identified 229 patients – 93 were intubated and 136 were started on NIV. Patients on NIV tended to be older (median age, 73 vs. 68 years), but there were no significant differences in baseline characteristics.

There were no significant differences in mortality for the overall cohort (46% vs. 33%), cardiac care unit length of stay (9 days in each group), or hospital length of stay (20 days vs. 17 days).

However, 101 (74%) patients failed NIV and required endotracheal intubation. Of the 101 patients in the NIV failure group, 50 (49.5%) required vasopressors, compared with 4 of the 35 patients (11.4%) who were successfully maintained on NIV.

As in the study by Dr. Gavilanes and his colleagues, there were significantly more deaths among patients who failed NIV (53 vs. 8; P = .002), as well as hemodynamic instability (54 vs. 8; P less than .001), and lactic acidosis (31 vs. 2; P =.003).

 

 

"Patients with CAP treated with NIV have a high likelihood of requiring intubation and developing significant complications. Patients started on NIV for severe CAP should be considered for early intubation if found to require vasopressor or have persistent hypoxemia/acidosis," Dr. Murad said.

Both studies were internally funded. Dr. Gavilanes and Dr. Murad each reported having no financial disclosures.

[email protected]

SAN JUAN, P.R.  – Noninvasive ventilation can be safely initiated and monitored on a general medical ward, taking some of the pressure off intensive care units, investigators reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

A retrospective study comparing outcomes for patients started on noninvasive ventilation (NIV) on general floors with those of patients put on NIV in the ICU showed that patients on the general wards were less likely to need intubation and had a shorter length of stay, but with mortality similar to that of ICU-treated patients, reported Dr. Edison Gavilanes, a resident in internal medicine at New York Hospital Queens.

If the patients started on noninvasive ventilation have community-acquired pneumonia (CAP), however, there is a high likelihood that they will eventually need to be intubated, cautioned Dr. Anwar Murad, an internal medicine resident at McGill University Health Centre, Montreal.

"Even though current evidence does not support NIV use in CAP, our data demonstrate that it is commonly employed in critical care units," Dr. Murad said in a poster presentation.

NIV in general

The New York researchers noted that, although current guidelines recommend that patients be started on NIV in the ICU and transferred to a step-down unit when they are stable, there are "little data to suggest that NIV on general wards is unsafe or that it could have an effect on mortality."

To see whether it was safe to start patients on NIV in general wards, they took a retrospective look at the records of 647 patients treated with NIV in 2011, collecting both clinical and demographic parameters as well as physiologic measures, including pH levels, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), and serum bicarbonate.

They found that, compared with the 184 patients in whom NIV was initiated in the ICU, the group of 463 patients started on NIV on the general wards had a higher mean age (77.8 vs. 73.1 years), more females than males (56.6% vs. 41.8%), higher mean pCO2 (51.4 vs. 42.9 mm Hg; P less than .0001), and was more likely to have respiratory failure from pulmonary causes rather than heart failure (69.8% vs. 51.1%; P less than .007).

Patients in the general wards had a significantly lower incidence of intubation (14.5% vs. 47.3%; P less than .0001) and shorter length of stay (11.6 vs. 15.9 days; P = .0001), Dr. Gavilanes reported.

There was no significant difference in mortality.

Variables associated with failure of an NIV trial on the floor and transfer to the ICU included the presence of metabolic acidosis, vasopressor requirement, and need for intubation. Patients who required transfer to the ICU had a higher mortality rate than did those who did not require it (62.9% vs. 27.6%; P less than .0001).

The investigators noted that "93% of the patients in whom NIV was started on the general medical wards did not require eventual ICU transfer or have increased mortality. However, patients with hemodynamic instability and metabolic acidosis can fail NIV and might benefit from ICU level monitoring."

NIV common for CAP

The Canadian researchers examined whether NIV was safe in patients with community-acquired pneumonia.

"Despite a lack of data supporting its use, NIV is commonly used in the management of patients with CAP. It is unclear which patients benefit from NIV and avoid endotracheal intubation," Dr. Murad said.

He and his associates conducted a retrospective cohort study of records on patients admitted to three critical care units from 2007 to 2012 with a diagnosis of CAP who were started on either noninvasive or invasive ventilation.

They identified 229 patients – 93 were intubated and 136 were started on NIV. Patients on NIV tended to be older (median age, 73 vs. 68 years), but there were no significant differences in baseline characteristics.

There were no significant differences in mortality for the overall cohort (46% vs. 33%), cardiac care unit length of stay (9 days in each group), or hospital length of stay (20 days vs. 17 days).

However, 101 (74%) patients failed NIV and required endotracheal intubation. Of the 101 patients in the NIV failure group, 50 (49.5%) required vasopressors, compared with 4 of the 35 patients (11.4%) who were successfully maintained on NIV.

As in the study by Dr. Gavilanes and his colleagues, there were significantly more deaths among patients who failed NIV (53 vs. 8; P = .002), as well as hemodynamic instability (54 vs. 8; P less than .001), and lactic acidosis (31 vs. 2; P =.003).

 

 

"Patients with CAP treated with NIV have a high likelihood of requiring intubation and developing significant complications. Patients started on NIV for severe CAP should be considered for early intubation if found to require vasopressor or have persistent hypoxemia/acidosis," Dr. Murad said.

Both studies were internally funded. Dr. Gavilanes and Dr. Murad each reported having no financial disclosures.

[email protected]

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Beta-2 agonists don't reduce mortality from ARDS

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Beta-2 agonists don't reduce mortality from ARDS

SAN JUAN, P.R. – Beta-2 agonists neither reduce mortality nor shorten hospital stays for patients with acute lung injury or acute respiratory distress syndrome, investigators reported at the Critical Care Congress.

A systematic review and meta-analysis showed that in randomized controlled trials, patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) who received either intravenous or aerosolized beta-2 agonists did not have significantly lower in-hospital or 28-day mortality than that of similar patients who did not receive the drugs.

"The current evidence discourages the use of beta-2 agonists among ALI/ARDS patients," Dr. Balwinder Singh, a research fellow in pulmonary and critical care medicine at the Mayo Clinic in Rochester, Minn., and his colleagues wrote in a poster.

In one of the studies included in the meta-analysis – the Beta-Agonist Lung Injury Trial (BALTI), published in 2006 – investigators in the United Kingdom found that patients randomly assigned to receive intravenous albuterol (salbutamol in the United Kingdom) had significantly lower amounts of lung water and plateau airway pressures than did controls (Am. J. Respir. Crit. Care Med. 173;3:281-7). This finding, plus evidence from preclinical studies, prompted other researchers to investigate whether beta-2 agonists could improve survival and other important outcomes.

In a 2011 study, investigators from the ARDS Clinical Trials Network noted that the rationale for the use of beta-2 adrenergic receptor agonists in patients with ALI/ARDS is that they had been shown to accelerate the resolution of pulmonary edema in preclinical studies and in a single controlled trial, and that "decreased resolution of alveolar edema is associated with increased mortality" (Am. J. Respir. Crit. Care Med. 2011;184:561-68).

To see whether those ideas hold water, Dr. Singh and his colleagues trolled the medical literature for randomized controlled trials that used a beta-2 agonist for ALI.

They reviewed 204 total studies, settling on three randomized controlled trials, including the two aforementioned studies and the BALTI-2 trial (Lancet 2012;379:229-35). The studies showed either mortality rates or ventilator-free days for patients on beta-2 agonists, or both. The studies followed a total of 646 patients, of whom 334 (51.7%) were prescribed a beta-2 agonist.

The beta-2 agonists were not associated with a significant decrease in 28-day mortality (relative risk, 1.04; 95% confidence interval, 0.50-2.16) or in-hospital mortality (RR, 1.22; CI, 0.95-1.56).

In addition, patients who received a beta-2 agonist had markedly fewer ventilator-free days, with a mean difference of –2.20 days (CI, –2.41 to –1.99).

The conclusion of Dr. Singh and his colleagues – that the evidence weighs against the use of beta-2 agonists in ALI/ARDS – echoes that of the BALTI-2 researchers, who wrote, "Findings from this multicentre trial provide evidence that intravenous salbutamol in the early course of ARDS was poorly tolerated, is unlikely to be beneficial, and could worsen outcomes. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."

The Critical Care Congress was sponsored by the Society for Critical Care Medicine.

The study was internally funded. Dr. Singh reported having no financial disclosures.

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SAN JUAN, P.R. – Beta-2 agonists neither reduce mortality nor shorten hospital stays for patients with acute lung injury or acute respiratory distress syndrome, investigators reported at the Critical Care Congress.

A systematic review and meta-analysis showed that in randomized controlled trials, patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) who received either intravenous or aerosolized beta-2 agonists did not have significantly lower in-hospital or 28-day mortality than that of similar patients who did not receive the drugs.

"The current evidence discourages the use of beta-2 agonists among ALI/ARDS patients," Dr. Balwinder Singh, a research fellow in pulmonary and critical care medicine at the Mayo Clinic in Rochester, Minn., and his colleagues wrote in a poster.

In one of the studies included in the meta-analysis – the Beta-Agonist Lung Injury Trial (BALTI), published in 2006 – investigators in the United Kingdom found that patients randomly assigned to receive intravenous albuterol (salbutamol in the United Kingdom) had significantly lower amounts of lung water and plateau airway pressures than did controls (Am. J. Respir. Crit. Care Med. 173;3:281-7). This finding, plus evidence from preclinical studies, prompted other researchers to investigate whether beta-2 agonists could improve survival and other important outcomes.

In a 2011 study, investigators from the ARDS Clinical Trials Network noted that the rationale for the use of beta-2 adrenergic receptor agonists in patients with ALI/ARDS is that they had been shown to accelerate the resolution of pulmonary edema in preclinical studies and in a single controlled trial, and that "decreased resolution of alveolar edema is associated with increased mortality" (Am. J. Respir. Crit. Care Med. 2011;184:561-68).

To see whether those ideas hold water, Dr. Singh and his colleagues trolled the medical literature for randomized controlled trials that used a beta-2 agonist for ALI.

They reviewed 204 total studies, settling on three randomized controlled trials, including the two aforementioned studies and the BALTI-2 trial (Lancet 2012;379:229-35). The studies showed either mortality rates or ventilator-free days for patients on beta-2 agonists, or both. The studies followed a total of 646 patients, of whom 334 (51.7%) were prescribed a beta-2 agonist.

The beta-2 agonists were not associated with a significant decrease in 28-day mortality (relative risk, 1.04; 95% confidence interval, 0.50-2.16) or in-hospital mortality (RR, 1.22; CI, 0.95-1.56).

In addition, patients who received a beta-2 agonist had markedly fewer ventilator-free days, with a mean difference of –2.20 days (CI, –2.41 to –1.99).

The conclusion of Dr. Singh and his colleagues – that the evidence weighs against the use of beta-2 agonists in ALI/ARDS – echoes that of the BALTI-2 researchers, who wrote, "Findings from this multicentre trial provide evidence that intravenous salbutamol in the early course of ARDS was poorly tolerated, is unlikely to be beneficial, and could worsen outcomes. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."

The Critical Care Congress was sponsored by the Society for Critical Care Medicine.

The study was internally funded. Dr. Singh reported having no financial disclosures.

SAN JUAN, P.R. – Beta-2 agonists neither reduce mortality nor shorten hospital stays for patients with acute lung injury or acute respiratory distress syndrome, investigators reported at the Critical Care Congress.

A systematic review and meta-analysis showed that in randomized controlled trials, patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) who received either intravenous or aerosolized beta-2 agonists did not have significantly lower in-hospital or 28-day mortality than that of similar patients who did not receive the drugs.

"The current evidence discourages the use of beta-2 agonists among ALI/ARDS patients," Dr. Balwinder Singh, a research fellow in pulmonary and critical care medicine at the Mayo Clinic in Rochester, Minn., and his colleagues wrote in a poster.

In one of the studies included in the meta-analysis – the Beta-Agonist Lung Injury Trial (BALTI), published in 2006 – investigators in the United Kingdom found that patients randomly assigned to receive intravenous albuterol (salbutamol in the United Kingdom) had significantly lower amounts of lung water and plateau airway pressures than did controls (Am. J. Respir. Crit. Care Med. 173;3:281-7). This finding, plus evidence from preclinical studies, prompted other researchers to investigate whether beta-2 agonists could improve survival and other important outcomes.

In a 2011 study, investigators from the ARDS Clinical Trials Network noted that the rationale for the use of beta-2 adrenergic receptor agonists in patients with ALI/ARDS is that they had been shown to accelerate the resolution of pulmonary edema in preclinical studies and in a single controlled trial, and that "decreased resolution of alveolar edema is associated with increased mortality" (Am. J. Respir. Crit. Care Med. 2011;184:561-68).

To see whether those ideas hold water, Dr. Singh and his colleagues trolled the medical literature for randomized controlled trials that used a beta-2 agonist for ALI.

They reviewed 204 total studies, settling on three randomized controlled trials, including the two aforementioned studies and the BALTI-2 trial (Lancet 2012;379:229-35). The studies showed either mortality rates or ventilator-free days for patients on beta-2 agonists, or both. The studies followed a total of 646 patients, of whom 334 (51.7%) were prescribed a beta-2 agonist.

The beta-2 agonists were not associated with a significant decrease in 28-day mortality (relative risk, 1.04; 95% confidence interval, 0.50-2.16) or in-hospital mortality (RR, 1.22; CI, 0.95-1.56).

In addition, patients who received a beta-2 agonist had markedly fewer ventilator-free days, with a mean difference of –2.20 days (CI, –2.41 to –1.99).

The conclusion of Dr. Singh and his colleagues – that the evidence weighs against the use of beta-2 agonists in ALI/ARDS – echoes that of the BALTI-2 researchers, who wrote, "Findings from this multicentre trial provide evidence that intravenous salbutamol in the early course of ARDS was poorly tolerated, is unlikely to be beneficial, and could worsen outcomes. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."

The Critical Care Congress was sponsored by the Society for Critical Care Medicine.

The study was internally funded. Dr. Singh reported having no financial disclosures.

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Are $100,000-plus ICU drugs worth the cost?

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Are $100,000-plus ICU drugs worth the cost?

Yes – Expensive drugs may offset other costs.

As in every aspect of medicine, there is a cost-benefit balance, with the cost of care being weighed against the benefits of a favorable outcome. The debate seems to be complex, but it can really be boiled down to a single question: Is the therapy worth using when compared with alternatives or to current practice?

It is incumbent upon us as clinicians to evaluate the appropriate use of both expensive and inexpensive drugs.

Drug costs in the ICU always involve more than meets the eye. If we take the traditional silo-based perspective and focus only on the acquisition cost of a drug, we’re ignoring the reality that the less expensive drug is not always the best drug for a condition and that health system costs are affected by the total cost of care. If a less expensive drug requires more patient monitoring, it offsets at least some of the cost advantage by adding higher laboratory or imaging costs.

Another consideration for the hospital is the reimbursement climate. Hospitals that receive low scores on pain management under the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey may experience significant reductions in reimbursement. So if, say, an expensive nonopioid analgesic used as part of a multimodal therapy could significantly improve pain control and reduce opioid-related adverse events, the extra cost could be justified.

Acquisition costs are only part of a drug’s total cost, which also includes the costs of preparation, storage, administration (such as infusion devices), lab monitoring, treating adverse drug events, and, of course, failed therapy.

Costly drugs also may pay for themselves by offsetting other costs. A new, costly drug that reduces the patient’s length of ICU stay by 1 day would save $4,000 to $5,000, and a drug that reduces time spent on a mechanical ventilator could reduce costs by about $1,900 for each ventilator-free day. Ventilator-associated pneumonias cost approximately $50,000 more per case ($70,580 vs. $21,620), but prevention strategies, including the use of medications, could reduce these costs.

Our group recently did a study of ICU costs associated with acute kidney injury following coronary artery bypass grafts and found that costs were twice as high in patients with kidney injury ($25,950 vs. $13,830). If patients have even a 1.5-fold increase over baseline in serum creatinine, the associated cost is $21,775, compared with $13,830 in patients whose serum creatinine is controlled. We calculated that an effective drug, if it cost less than $12,000, would offset these costs (Textbook of Critical Care, 6th edition, 2011, pp. 1387-92).

A 2012 analysis of the cost offset of tolvaptan in patients with inappropriate antidiuretic hormone secretion indicated that the cost of treating hyponatremia was $1,694 and that tolvaptan, at a cost of $250 per day for 4 days, reduced the length of stay by an estimated 1.1 days, thereby providing a savings of $694 per patient (Hosp. Pract. 2012;40:7-14).

Similarly, recombinant factor VIIa costs $7,000 to $10,000 per dose, but when used for its approved indication – bleeding episodes in hemophilia A or B patients with inhibitors to factors VIII/IX and for prevention of bleeding during surgical intervention in these patients – costs per resolved bleeding episode were $3,000 to $17,000 lower than for patients given activated prothrombin complex concentrate (Haemophilia 2009;15:405-19).

Clinicians are excited when we have new options for therapy, but we have to figure out where a new, expensive therapy fits. Does it make sense to use it? What is the efficacy of the drug relative to its costs? The key to the appropriate use of drugs, both costly and cheap, is to develop a disease state–based protocol tailored to your institution’s specific usage patterns, case mix, economic climate, and politics.

Dr. Sandra Kane-Gill is associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. She also serves as associate professor for the Center for Pharmacoinformatics and Outcomes Research at the School of Pharmacy.

No – With cost evaluations, the devil is in the details.

Drug-cost evaluations look great on paper, but they often don’t work in the real world. An expensive drug may let you take a patient off a ventilator earlier, but if you can’t send the patient to the floor because there is no available bed and you can’t let that patient’s nurse go home, there may not be a true savings in cost.

As Dr. Kane-Gill points out, the problem is complex and there are many analytic approaches. We can consider whether we have therapeutically equivalent options, balance the cost-effectiveness and cost-benefit ratios of treatments with different outcomes, or consider patient preference measured in cost-utility tradeoff and expressed as quality-adjusted life years (QALYs).

 

 

The problem with cost modeling is that it is sensitive to input – garbage in means garbage out. Models are hampered by the limitations of what can be accomplished in clinical trials and by the assumptions made to create the model. Is it based on acquisition costs or on charges? How do practice variations within the institution (between the medical ICU and the surgical ICU, for example), or from one institution to the next, affect the assumptions in the model?

Cost comparisons must somehow reconcile data from conflicting studies and multiple treatment options, and they must be able to quantify the effects over time of a given intervention.

Clinical trials that are used to justify cost evaluations are performed in controlled settings. I wish that I could say that all my patients were uniform, but they are not. There is a substantial difference between a 24-year-old with a head injury and a 90-year-old with a head injury, or between a patient with a broken hip and one with end-stage liver disease. How do you begin to compare the effects of drugs across these populations? How do you judge the effect of a specific drug in an era of polypharmacy, when some patients seen in our unit have been on as many as 27 drugs at the same time?

Time can also fade the bloom of a once-promising drug, such as drotrecogin alfa (Xigris). An analysis of the PROWESS study (Crit. Care Med. 2003;31:12-9) appeared to show that drotrecogin alfa was helpful in patients with severe sepsis, and this drug’s alleged efficacy was balanced against its cost, which was estimated at $48,000 per QALY and considered to be in the acceptable range. As we all know, longer experience with this agent found no overall benefit and an association with higher bleeding risk (Cochrane Database Syst. Rev. 2012 Dec 12;12:CD004388). The drug was pulled from the market in late 2011.

Dr. Kane-Gill correctly notes that factor VIIa, when used for its rare indication, offers a benefit and saves money. But many ICUs were using this agent outside of its labeled indication (Ann. Intern. Med. 2011;154:516-22) and found that it caused emboli in patients already at risk for thromboembolic events (J. Trauma. 2010;69:489-500; N. Engl. J. Med. 2008;358:2127-37).

If a drug is in the formulary, and if it is new and more expensive than other therapeutic options, it is human nature to think that new and expensive must mean better than old and cheap. In Europe, ICUs routinely use injectable acetaminophen for nonopioid pain relief. In the United States, the intravenous formulations of this drug are costly – about $10 per dose, compared with about 50 cents for one dose of percocet. Yet the reduction in opioid use with the injectable agent is modest, there is no evidence to suggest reductions in opioid-related adverse events, and there are conflicting data on patient satisfaction (Cochrane Database Syst. Rev. 2011 Oct 5;(10):CD007126).

Economic evaluations of drugs should be viewed with caution because they require knowledge of the literature basis for the model, may exhibit considerable variation in estimates of indirect costs, and are subject to the vagaries of conflicting data as well as changes in data and practice over time. Additionally, estimates of drug cost and benefits can vary by country, region, or facility.

It’s clear that we need much more data about outcomes and the true costs of the care we give.

Dr. Christine C. Toevs is a trauma surgeon and director of the trauma ICU at Allegheny General Hospital in Pittsburgh. She also has a Masters degree in bioethics.

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Yes – Expensive drugs may offset other costs.

As in every aspect of medicine, there is a cost-benefit balance, with the cost of care being weighed against the benefits of a favorable outcome. The debate seems to be complex, but it can really be boiled down to a single question: Is the therapy worth using when compared with alternatives or to current practice?

It is incumbent upon us as clinicians to evaluate the appropriate use of both expensive and inexpensive drugs.

Drug costs in the ICU always involve more than meets the eye. If we take the traditional silo-based perspective and focus only on the acquisition cost of a drug, we’re ignoring the reality that the less expensive drug is not always the best drug for a condition and that health system costs are affected by the total cost of care. If a less expensive drug requires more patient monitoring, it offsets at least some of the cost advantage by adding higher laboratory or imaging costs.

Another consideration for the hospital is the reimbursement climate. Hospitals that receive low scores on pain management under the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey may experience significant reductions in reimbursement. So if, say, an expensive nonopioid analgesic used as part of a multimodal therapy could significantly improve pain control and reduce opioid-related adverse events, the extra cost could be justified.

Acquisition costs are only part of a drug’s total cost, which also includes the costs of preparation, storage, administration (such as infusion devices), lab monitoring, treating adverse drug events, and, of course, failed therapy.

Costly drugs also may pay for themselves by offsetting other costs. A new, costly drug that reduces the patient’s length of ICU stay by 1 day would save $4,000 to $5,000, and a drug that reduces time spent on a mechanical ventilator could reduce costs by about $1,900 for each ventilator-free day. Ventilator-associated pneumonias cost approximately $50,000 more per case ($70,580 vs. $21,620), but prevention strategies, including the use of medications, could reduce these costs.

Our group recently did a study of ICU costs associated with acute kidney injury following coronary artery bypass grafts and found that costs were twice as high in patients with kidney injury ($25,950 vs. $13,830). If patients have even a 1.5-fold increase over baseline in serum creatinine, the associated cost is $21,775, compared with $13,830 in patients whose serum creatinine is controlled. We calculated that an effective drug, if it cost less than $12,000, would offset these costs (Textbook of Critical Care, 6th edition, 2011, pp. 1387-92).

A 2012 analysis of the cost offset of tolvaptan in patients with inappropriate antidiuretic hormone secretion indicated that the cost of treating hyponatremia was $1,694 and that tolvaptan, at a cost of $250 per day for 4 days, reduced the length of stay by an estimated 1.1 days, thereby providing a savings of $694 per patient (Hosp. Pract. 2012;40:7-14).

Similarly, recombinant factor VIIa costs $7,000 to $10,000 per dose, but when used for its approved indication – bleeding episodes in hemophilia A or B patients with inhibitors to factors VIII/IX and for prevention of bleeding during surgical intervention in these patients – costs per resolved bleeding episode were $3,000 to $17,000 lower than for patients given activated prothrombin complex concentrate (Haemophilia 2009;15:405-19).

Clinicians are excited when we have new options for therapy, but we have to figure out where a new, expensive therapy fits. Does it make sense to use it? What is the efficacy of the drug relative to its costs? The key to the appropriate use of drugs, both costly and cheap, is to develop a disease state–based protocol tailored to your institution’s specific usage patterns, case mix, economic climate, and politics.

Dr. Sandra Kane-Gill is associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. She also serves as associate professor for the Center for Pharmacoinformatics and Outcomes Research at the School of Pharmacy.

No – With cost evaluations, the devil is in the details.

Drug-cost evaluations look great on paper, but they often don’t work in the real world. An expensive drug may let you take a patient off a ventilator earlier, but if you can’t send the patient to the floor because there is no available bed and you can’t let that patient’s nurse go home, there may not be a true savings in cost.

As Dr. Kane-Gill points out, the problem is complex and there are many analytic approaches. We can consider whether we have therapeutically equivalent options, balance the cost-effectiveness and cost-benefit ratios of treatments with different outcomes, or consider patient preference measured in cost-utility tradeoff and expressed as quality-adjusted life years (QALYs).

 

 

The problem with cost modeling is that it is sensitive to input – garbage in means garbage out. Models are hampered by the limitations of what can be accomplished in clinical trials and by the assumptions made to create the model. Is it based on acquisition costs or on charges? How do practice variations within the institution (between the medical ICU and the surgical ICU, for example), or from one institution to the next, affect the assumptions in the model?

Cost comparisons must somehow reconcile data from conflicting studies and multiple treatment options, and they must be able to quantify the effects over time of a given intervention.

Clinical trials that are used to justify cost evaluations are performed in controlled settings. I wish that I could say that all my patients were uniform, but they are not. There is a substantial difference between a 24-year-old with a head injury and a 90-year-old with a head injury, or between a patient with a broken hip and one with end-stage liver disease. How do you begin to compare the effects of drugs across these populations? How do you judge the effect of a specific drug in an era of polypharmacy, when some patients seen in our unit have been on as many as 27 drugs at the same time?

Time can also fade the bloom of a once-promising drug, such as drotrecogin alfa (Xigris). An analysis of the PROWESS study (Crit. Care Med. 2003;31:12-9) appeared to show that drotrecogin alfa was helpful in patients with severe sepsis, and this drug’s alleged efficacy was balanced against its cost, which was estimated at $48,000 per QALY and considered to be in the acceptable range. As we all know, longer experience with this agent found no overall benefit and an association with higher bleeding risk (Cochrane Database Syst. Rev. 2012 Dec 12;12:CD004388). The drug was pulled from the market in late 2011.

Dr. Kane-Gill correctly notes that factor VIIa, when used for its rare indication, offers a benefit and saves money. But many ICUs were using this agent outside of its labeled indication (Ann. Intern. Med. 2011;154:516-22) and found that it caused emboli in patients already at risk for thromboembolic events (J. Trauma. 2010;69:489-500; N. Engl. J. Med. 2008;358:2127-37).

If a drug is in the formulary, and if it is new and more expensive than other therapeutic options, it is human nature to think that new and expensive must mean better than old and cheap. In Europe, ICUs routinely use injectable acetaminophen for nonopioid pain relief. In the United States, the intravenous formulations of this drug are costly – about $10 per dose, compared with about 50 cents for one dose of percocet. Yet the reduction in opioid use with the injectable agent is modest, there is no evidence to suggest reductions in opioid-related adverse events, and there are conflicting data on patient satisfaction (Cochrane Database Syst. Rev. 2011 Oct 5;(10):CD007126).

Economic evaluations of drugs should be viewed with caution because they require knowledge of the literature basis for the model, may exhibit considerable variation in estimates of indirect costs, and are subject to the vagaries of conflicting data as well as changes in data and practice over time. Additionally, estimates of drug cost and benefits can vary by country, region, or facility.

It’s clear that we need much more data about outcomes and the true costs of the care we give.

Dr. Christine C. Toevs is a trauma surgeon and director of the trauma ICU at Allegheny General Hospital in Pittsburgh. She also has a Masters degree in bioethics.

Yes – Expensive drugs may offset other costs.

As in every aspect of medicine, there is a cost-benefit balance, with the cost of care being weighed against the benefits of a favorable outcome. The debate seems to be complex, but it can really be boiled down to a single question: Is the therapy worth using when compared with alternatives or to current practice?

It is incumbent upon us as clinicians to evaluate the appropriate use of both expensive and inexpensive drugs.

Drug costs in the ICU always involve more than meets the eye. If we take the traditional silo-based perspective and focus only on the acquisition cost of a drug, we’re ignoring the reality that the less expensive drug is not always the best drug for a condition and that health system costs are affected by the total cost of care. If a less expensive drug requires more patient monitoring, it offsets at least some of the cost advantage by adding higher laboratory or imaging costs.

Another consideration for the hospital is the reimbursement climate. Hospitals that receive low scores on pain management under the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey may experience significant reductions in reimbursement. So if, say, an expensive nonopioid analgesic used as part of a multimodal therapy could significantly improve pain control and reduce opioid-related adverse events, the extra cost could be justified.

Acquisition costs are only part of a drug’s total cost, which also includes the costs of preparation, storage, administration (such as infusion devices), lab monitoring, treating adverse drug events, and, of course, failed therapy.

Costly drugs also may pay for themselves by offsetting other costs. A new, costly drug that reduces the patient’s length of ICU stay by 1 day would save $4,000 to $5,000, and a drug that reduces time spent on a mechanical ventilator could reduce costs by about $1,900 for each ventilator-free day. Ventilator-associated pneumonias cost approximately $50,000 more per case ($70,580 vs. $21,620), but prevention strategies, including the use of medications, could reduce these costs.

Our group recently did a study of ICU costs associated with acute kidney injury following coronary artery bypass grafts and found that costs were twice as high in patients with kidney injury ($25,950 vs. $13,830). If patients have even a 1.5-fold increase over baseline in serum creatinine, the associated cost is $21,775, compared with $13,830 in patients whose serum creatinine is controlled. We calculated that an effective drug, if it cost less than $12,000, would offset these costs (Textbook of Critical Care, 6th edition, 2011, pp. 1387-92).

A 2012 analysis of the cost offset of tolvaptan in patients with inappropriate antidiuretic hormone secretion indicated that the cost of treating hyponatremia was $1,694 and that tolvaptan, at a cost of $250 per day for 4 days, reduced the length of stay by an estimated 1.1 days, thereby providing a savings of $694 per patient (Hosp. Pract. 2012;40:7-14).

Similarly, recombinant factor VIIa costs $7,000 to $10,000 per dose, but when used for its approved indication – bleeding episodes in hemophilia A or B patients with inhibitors to factors VIII/IX and for prevention of bleeding during surgical intervention in these patients – costs per resolved bleeding episode were $3,000 to $17,000 lower than for patients given activated prothrombin complex concentrate (Haemophilia 2009;15:405-19).

Clinicians are excited when we have new options for therapy, but we have to figure out where a new, expensive therapy fits. Does it make sense to use it? What is the efficacy of the drug relative to its costs? The key to the appropriate use of drugs, both costly and cheap, is to develop a disease state–based protocol tailored to your institution’s specific usage patterns, case mix, economic climate, and politics.

Dr. Sandra Kane-Gill is associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. She also serves as associate professor for the Center for Pharmacoinformatics and Outcomes Research at the School of Pharmacy.

No – With cost evaluations, the devil is in the details.

Drug-cost evaluations look great on paper, but they often don’t work in the real world. An expensive drug may let you take a patient off a ventilator earlier, but if you can’t send the patient to the floor because there is no available bed and you can’t let that patient’s nurse go home, there may not be a true savings in cost.

As Dr. Kane-Gill points out, the problem is complex and there are many analytic approaches. We can consider whether we have therapeutically equivalent options, balance the cost-effectiveness and cost-benefit ratios of treatments with different outcomes, or consider patient preference measured in cost-utility tradeoff and expressed as quality-adjusted life years (QALYs).

 

 

The problem with cost modeling is that it is sensitive to input – garbage in means garbage out. Models are hampered by the limitations of what can be accomplished in clinical trials and by the assumptions made to create the model. Is it based on acquisition costs or on charges? How do practice variations within the institution (between the medical ICU and the surgical ICU, for example), or from one institution to the next, affect the assumptions in the model?

Cost comparisons must somehow reconcile data from conflicting studies and multiple treatment options, and they must be able to quantify the effects over time of a given intervention.

Clinical trials that are used to justify cost evaluations are performed in controlled settings. I wish that I could say that all my patients were uniform, but they are not. There is a substantial difference between a 24-year-old with a head injury and a 90-year-old with a head injury, or between a patient with a broken hip and one with end-stage liver disease. How do you begin to compare the effects of drugs across these populations? How do you judge the effect of a specific drug in an era of polypharmacy, when some patients seen in our unit have been on as many as 27 drugs at the same time?

Time can also fade the bloom of a once-promising drug, such as drotrecogin alfa (Xigris). An analysis of the PROWESS study (Crit. Care Med. 2003;31:12-9) appeared to show that drotrecogin alfa was helpful in patients with severe sepsis, and this drug’s alleged efficacy was balanced against its cost, which was estimated at $48,000 per QALY and considered to be in the acceptable range. As we all know, longer experience with this agent found no overall benefit and an association with higher bleeding risk (Cochrane Database Syst. Rev. 2012 Dec 12;12:CD004388). The drug was pulled from the market in late 2011.

Dr. Kane-Gill correctly notes that factor VIIa, when used for its rare indication, offers a benefit and saves money. But many ICUs were using this agent outside of its labeled indication (Ann. Intern. Med. 2011;154:516-22) and found that it caused emboli in patients already at risk for thromboembolic events (J. Trauma. 2010;69:489-500; N. Engl. J. Med. 2008;358:2127-37).

If a drug is in the formulary, and if it is new and more expensive than other therapeutic options, it is human nature to think that new and expensive must mean better than old and cheap. In Europe, ICUs routinely use injectable acetaminophen for nonopioid pain relief. In the United States, the intravenous formulations of this drug are costly – about $10 per dose, compared with about 50 cents for one dose of percocet. Yet the reduction in opioid use with the injectable agent is modest, there is no evidence to suggest reductions in opioid-related adverse events, and there are conflicting data on patient satisfaction (Cochrane Database Syst. Rev. 2011 Oct 5;(10):CD007126).

Economic evaluations of drugs should be viewed with caution because they require knowledge of the literature basis for the model, may exhibit considerable variation in estimates of indirect costs, and are subject to the vagaries of conflicting data as well as changes in data and practice over time. Additionally, estimates of drug cost and benefits can vary by country, region, or facility.

It’s clear that we need much more data about outcomes and the true costs of the care we give.

Dr. Christine C. Toevs is a trauma surgeon and director of the trauma ICU at Allegheny General Hospital in Pittsburgh. She also has a Masters degree in bioethics.

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Ulnar length can predict optimal endotracheal tube depth

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Ulnar length can predict optimal endotracheal tube depth

SAN JUAN, P.R.  – Measure twice, intubate once – good thinking alongside a pilot study that suggests a simple formula based on the length of a child’s ulna can accurately predict the optimal depth for endotracheal tube insertion. The formula could save time and spare children from unnecessary radiation, investigators said at the annual congress of the Society of Critical Care Medicine.

A study of 121 orally intubated children (median age, 35.7 months) in a pediatric and a cardiothoracic intensive care unit showed that the ulna could be accurately measured with digital calipers in children with varying body habitus, as well as those with neuromuscular disease, and that a simple formula based on the measurement provides a good estimate of the best tube insertion depth, said Dr. Anne Camerlengo, a fellow in pediatric critical care at Children’s Hospital Los Angeles, and her colleagues.

Dr. Anne Camerlengo

"While the chest radiograph is the gold standard for determining tube placement, several nonradiographic techniques have been described, including formulas based on the patient’s weight, height, or gestational age, or the endotracheal tube diameter. However, these formulas may be less accurate for our patients with scoliosis or neuromuscular diseases that affect their height, while ulnar length is a measure that’s preserved in this population," she said in a poster session.

To see whether they could derive an accurate predictive equation for determining optimal endotracheal tube depth – 2 cm above the carina of the trachea – the investigators used chest radiographs to measure the distance from the endotracheal tube to the carina in intubated children, and recorded their ulnar length, height, and depth of endotracheal tube insertion.

They determined the optimal tube depth to be the depth of insertion plus the distance from the tube to the carina, minus 2 cm. They then plotted the optimal tube position against ulnar length, and used linear regression to calculate the following predictive equation:

Depth of endotracheal tube insertion in centimeters equals 0.75 times the ulnar length in centimeters plus 4.4.

Dr. Camerlengo said that ulnar measurements are relatively easy to make, and that the only significant difficulty occurs with children who may be frightened by the appearance of the calipers with their pointed ends.

Dr. Alexandre T. Rotta

However, "given that most of these children are reasonably well sedated, there’s not usually an issue with cooperation or finding the bony landmarks. The ulnar length is particularly useful because the bony landmarks, even in our chubbier children, we are able to palpate deeply," she said.

The investigators need to collect additional data on nasally intubated patients before they can determine whether the formula can be applied to this population.

She said that they hope to expand the analysis to include subgroups based on patient age and the presence of neuromuscular disease, and emphasized that the formulas to determine the optimal depth for both oral and nasal endotracheal tubes will need to be confirmed in a validation study.

Dr. Alexandre T. Rotta, professor of pediatrics at Case Western Reserve University and chief of pediatric critical care at Rainbow Babies and Children’s Hospital, both in Cleveland, commented that the work is promising but needs to be put to the test.

"There has been a lot of work trying to look for the magic formula of how to place an endotracheal tube. I think that key now is to see whether this will be validated in real time. They validated the formula mathematically, so the question now is does it work for various patients under various conditions, and is it reproducible with my measurement versus her measurement," Dr. Rotta said in an interview.

He was not involved in the study, but comoderated the poster discussion session at which it was presented.

The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

[email protected]

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SAN JUAN, P.R.  – Measure twice, intubate once – good thinking alongside a pilot study that suggests a simple formula based on the length of a child’s ulna can accurately predict the optimal depth for endotracheal tube insertion. The formula could save time and spare children from unnecessary radiation, investigators said at the annual congress of the Society of Critical Care Medicine.

A study of 121 orally intubated children (median age, 35.7 months) in a pediatric and a cardiothoracic intensive care unit showed that the ulna could be accurately measured with digital calipers in children with varying body habitus, as well as those with neuromuscular disease, and that a simple formula based on the measurement provides a good estimate of the best tube insertion depth, said Dr. Anne Camerlengo, a fellow in pediatric critical care at Children’s Hospital Los Angeles, and her colleagues.

Dr. Anne Camerlengo

"While the chest radiograph is the gold standard for determining tube placement, several nonradiographic techniques have been described, including formulas based on the patient’s weight, height, or gestational age, or the endotracheal tube diameter. However, these formulas may be less accurate for our patients with scoliosis or neuromuscular diseases that affect their height, while ulnar length is a measure that’s preserved in this population," she said in a poster session.

To see whether they could derive an accurate predictive equation for determining optimal endotracheal tube depth – 2 cm above the carina of the trachea – the investigators used chest radiographs to measure the distance from the endotracheal tube to the carina in intubated children, and recorded their ulnar length, height, and depth of endotracheal tube insertion.

They determined the optimal tube depth to be the depth of insertion plus the distance from the tube to the carina, minus 2 cm. They then plotted the optimal tube position against ulnar length, and used linear regression to calculate the following predictive equation:

Depth of endotracheal tube insertion in centimeters equals 0.75 times the ulnar length in centimeters plus 4.4.

Dr. Camerlengo said that ulnar measurements are relatively easy to make, and that the only significant difficulty occurs with children who may be frightened by the appearance of the calipers with their pointed ends.

Dr. Alexandre T. Rotta

However, "given that most of these children are reasonably well sedated, there’s not usually an issue with cooperation or finding the bony landmarks. The ulnar length is particularly useful because the bony landmarks, even in our chubbier children, we are able to palpate deeply," she said.

The investigators need to collect additional data on nasally intubated patients before they can determine whether the formula can be applied to this population.

She said that they hope to expand the analysis to include subgroups based on patient age and the presence of neuromuscular disease, and emphasized that the formulas to determine the optimal depth for both oral and nasal endotracheal tubes will need to be confirmed in a validation study.

Dr. Alexandre T. Rotta, professor of pediatrics at Case Western Reserve University and chief of pediatric critical care at Rainbow Babies and Children’s Hospital, both in Cleveland, commented that the work is promising but needs to be put to the test.

"There has been a lot of work trying to look for the magic formula of how to place an endotracheal tube. I think that key now is to see whether this will be validated in real time. They validated the formula mathematically, so the question now is does it work for various patients under various conditions, and is it reproducible with my measurement versus her measurement," Dr. Rotta said in an interview.

He was not involved in the study, but comoderated the poster discussion session at which it was presented.

The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

[email protected]

SAN JUAN, P.R.  – Measure twice, intubate once – good thinking alongside a pilot study that suggests a simple formula based on the length of a child’s ulna can accurately predict the optimal depth for endotracheal tube insertion. The formula could save time and spare children from unnecessary radiation, investigators said at the annual congress of the Society of Critical Care Medicine.

A study of 121 orally intubated children (median age, 35.7 months) in a pediatric and a cardiothoracic intensive care unit showed that the ulna could be accurately measured with digital calipers in children with varying body habitus, as well as those with neuromuscular disease, and that a simple formula based on the measurement provides a good estimate of the best tube insertion depth, said Dr. Anne Camerlengo, a fellow in pediatric critical care at Children’s Hospital Los Angeles, and her colleagues.

Dr. Anne Camerlengo

"While the chest radiograph is the gold standard for determining tube placement, several nonradiographic techniques have been described, including formulas based on the patient’s weight, height, or gestational age, or the endotracheal tube diameter. However, these formulas may be less accurate for our patients with scoliosis or neuromuscular diseases that affect their height, while ulnar length is a measure that’s preserved in this population," she said in a poster session.

To see whether they could derive an accurate predictive equation for determining optimal endotracheal tube depth – 2 cm above the carina of the trachea – the investigators used chest radiographs to measure the distance from the endotracheal tube to the carina in intubated children, and recorded their ulnar length, height, and depth of endotracheal tube insertion.

They determined the optimal tube depth to be the depth of insertion plus the distance from the tube to the carina, minus 2 cm. They then plotted the optimal tube position against ulnar length, and used linear regression to calculate the following predictive equation:

Depth of endotracheal tube insertion in centimeters equals 0.75 times the ulnar length in centimeters plus 4.4.

Dr. Camerlengo said that ulnar measurements are relatively easy to make, and that the only significant difficulty occurs with children who may be frightened by the appearance of the calipers with their pointed ends.

Dr. Alexandre T. Rotta

However, "given that most of these children are reasonably well sedated, there’s not usually an issue with cooperation or finding the bony landmarks. The ulnar length is particularly useful because the bony landmarks, even in our chubbier children, we are able to palpate deeply," she said.

The investigators need to collect additional data on nasally intubated patients before they can determine whether the formula can be applied to this population.

She said that they hope to expand the analysis to include subgroups based on patient age and the presence of neuromuscular disease, and emphasized that the formulas to determine the optimal depth for both oral and nasal endotracheal tubes will need to be confirmed in a validation study.

Dr. Alexandre T. Rotta, professor of pediatrics at Case Western Reserve University and chief of pediatric critical care at Rainbow Babies and Children’s Hospital, both in Cleveland, commented that the work is promising but needs to be put to the test.

"There has been a lot of work trying to look for the magic formula of how to place an endotracheal tube. I think that key now is to see whether this will be validated in real time. They validated the formula mathematically, so the question now is does it work for various patients under various conditions, and is it reproducible with my measurement versus her measurement," Dr. Rotta said in an interview.

He was not involved in the study, but comoderated the poster discussion session at which it was presented.

The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

[email protected]

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Vitals

Major finding: Optimal depth of endotracheal tube insertion in centimeters equals 0.75 times ulnar length in centimeters plus 4.4.

Data source: Prospective study of 121 children with oral endotracheal tubes admitted to pediatric and cardiothoracic ICUs.

Disclosures: The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

Anticoagulant dabigatran ups the required dose of heparin

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Anticoagulant dabigatran ups the required dose of heparin

SAN JUAN, P.R. – The new oral anticoagulant dabigatran is the cardiologist’s darling but the intensivist’s headache and the trauma surgeon’s nightmare, suggested investigators here.

Dabigatran (Pradaxa) is a direct thrombin inhibitor approved in the United States for the reduction of risk from stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike Coumadin/warfarin, dabigatran’s effects are not reversible.

Neil Osterweil/IMNG Medical Media
Dr. Thomas Edrich discusses his research.

Pharmacists at the Scripps Mercy Hospital in San Diego evaluated prescribing patterns for dabigatran among patients in their hospital and found that 13% received it for off-label indications, a practice that has the potential for patient harm, they said at the annual meeting of the Society of Critical Care Medicine.

Of 38 patients prescribed dabigatran during their hospital stay, 33 received it for the Food and Drug Administration–approved indication but 5 (13%) received it for other, unspecified indications, reported Dr. Trevor Perry and Dr. Harminder Sikand, both clinical pharmacists at Scripps. "Prescribing was equally divided between house staff, hospitalists, and cardiologists," researchers reported (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000424500.73199.04]).

The incidence of gastrointestinal bleeding with the drug in their study was 10.5%, higher than the 6.1% rate for any gastrointestinal bleeding stated in the package insert, Dr. Perry said in an interview.

In addition, pharmacists needed to correct the dabigatran dose in 24% of patients, and dabigatran had noticeable effects on clotting parameters, with 74% of patients having an activated partial thromboplastin time (aPTT) above the upper limit of normal, and 64% of patients having an international normalized ratio (INR) above the upper limit.

This finding suggests that in these patients, the clotting assays "may be useful to determine medication adherence but not to determine the level of anticoagulation," the authors wrote in a poster presentation.

"Clinicians need to be aware of the appropriate indication for use and renal dosing of dabigatran to prevent patient harm, as only 87% of patients were prescribed dabigatran for the FDA-labeled indication," they noted.

Major heparin boost needed

In a separate study, Dr. Thomas Edrich from the department of anesthesiology, perioperative and pain medicine at Brigham & Women’s Hospital in Boston and his colleagues found that for patients scheduled for catheter-based atrial ablation procedures, those who were on dabigatran required an approximately 50% greater dose of heparin to achieve full anticoagulation for the procedure than did patients on warfarin (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000425177.10736.a4]).

Patients who had been on warfarin until 12 hours before the procedure required about 3,000-4,000 IU of heparin/hr to achieve an activated clotting time of 350 seconds, compared with about 6,500-9,000 IU/hr in patients on dabigatran, Dr. Edrich said. They studied retrospective data for 36 patients on dabigatran, 100 patients on warfarin (53 with an INR above 2.0), and 29 patients on no anticoagulation.

"The interesting finding here is that if you’ve been on dabigatran, you’re going to need twice as much heparin," he said in a poster discussion session.

Patients like it, surgeons don’t

Although patients like the convenience of oral dosing without the need for regular INR monitoring with the new anticoagulants, often they are not told that convenience may come at a very high price if there is no effective therapy to reverse the anticoagulation effect, commented Dr. Christine Toevs, a critical care surgeon at the West Penn Allegheny Health System in Pittsburgh.

"The problem is that patients aren\'t informed enough to make that choice. They understand that they’re not getting their labs drawn once a week or twice a week, and they understand that’s not a cost that they are paying. But if they fall and they have a head injury, that is a life lost, and we cannot stop it," she said during a debate on the costs of new medications.

Dr. Perry’s and Dr. Edrich’s studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.

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SAN JUAN, P.R. – The new oral anticoagulant dabigatran is the cardiologist’s darling but the intensivist’s headache and the trauma surgeon’s nightmare, suggested investigators here.

Dabigatran (Pradaxa) is a direct thrombin inhibitor approved in the United States for the reduction of risk from stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike Coumadin/warfarin, dabigatran’s effects are not reversible.

Neil Osterweil/IMNG Medical Media
Dr. Thomas Edrich discusses his research.

Pharmacists at the Scripps Mercy Hospital in San Diego evaluated prescribing patterns for dabigatran among patients in their hospital and found that 13% received it for off-label indications, a practice that has the potential for patient harm, they said at the annual meeting of the Society of Critical Care Medicine.

Of 38 patients prescribed dabigatran during their hospital stay, 33 received it for the Food and Drug Administration–approved indication but 5 (13%) received it for other, unspecified indications, reported Dr. Trevor Perry and Dr. Harminder Sikand, both clinical pharmacists at Scripps. "Prescribing was equally divided between house staff, hospitalists, and cardiologists," researchers reported (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000424500.73199.04]).

The incidence of gastrointestinal bleeding with the drug in their study was 10.5%, higher than the 6.1% rate for any gastrointestinal bleeding stated in the package insert, Dr. Perry said in an interview.

In addition, pharmacists needed to correct the dabigatran dose in 24% of patients, and dabigatran had noticeable effects on clotting parameters, with 74% of patients having an activated partial thromboplastin time (aPTT) above the upper limit of normal, and 64% of patients having an international normalized ratio (INR) above the upper limit.

This finding suggests that in these patients, the clotting assays "may be useful to determine medication adherence but not to determine the level of anticoagulation," the authors wrote in a poster presentation.

"Clinicians need to be aware of the appropriate indication for use and renal dosing of dabigatran to prevent patient harm, as only 87% of patients were prescribed dabigatran for the FDA-labeled indication," they noted.

Major heparin boost needed

In a separate study, Dr. Thomas Edrich from the department of anesthesiology, perioperative and pain medicine at Brigham & Women’s Hospital in Boston and his colleagues found that for patients scheduled for catheter-based atrial ablation procedures, those who were on dabigatran required an approximately 50% greater dose of heparin to achieve full anticoagulation for the procedure than did patients on warfarin (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000425177.10736.a4]).

Patients who had been on warfarin until 12 hours before the procedure required about 3,000-4,000 IU of heparin/hr to achieve an activated clotting time of 350 seconds, compared with about 6,500-9,000 IU/hr in patients on dabigatran, Dr. Edrich said. They studied retrospective data for 36 patients on dabigatran, 100 patients on warfarin (53 with an INR above 2.0), and 29 patients on no anticoagulation.

"The interesting finding here is that if you’ve been on dabigatran, you’re going to need twice as much heparin," he said in a poster discussion session.

Patients like it, surgeons don’t

Although patients like the convenience of oral dosing without the need for regular INR monitoring with the new anticoagulants, often they are not told that convenience may come at a very high price if there is no effective therapy to reverse the anticoagulation effect, commented Dr. Christine Toevs, a critical care surgeon at the West Penn Allegheny Health System in Pittsburgh.

"The problem is that patients aren\'t informed enough to make that choice. They understand that they’re not getting their labs drawn once a week or twice a week, and they understand that’s not a cost that they are paying. But if they fall and they have a head injury, that is a life lost, and we cannot stop it," she said during a debate on the costs of new medications.

Dr. Perry’s and Dr. Edrich’s studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.

SAN JUAN, P.R. – The new oral anticoagulant dabigatran is the cardiologist’s darling but the intensivist’s headache and the trauma surgeon’s nightmare, suggested investigators here.

Dabigatran (Pradaxa) is a direct thrombin inhibitor approved in the United States for the reduction of risk from stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike Coumadin/warfarin, dabigatran’s effects are not reversible.

Neil Osterweil/IMNG Medical Media
Dr. Thomas Edrich discusses his research.

Pharmacists at the Scripps Mercy Hospital in San Diego evaluated prescribing patterns for dabigatran among patients in their hospital and found that 13% received it for off-label indications, a practice that has the potential for patient harm, they said at the annual meeting of the Society of Critical Care Medicine.

Of 38 patients prescribed dabigatran during their hospital stay, 33 received it for the Food and Drug Administration–approved indication but 5 (13%) received it for other, unspecified indications, reported Dr. Trevor Perry and Dr. Harminder Sikand, both clinical pharmacists at Scripps. "Prescribing was equally divided between house staff, hospitalists, and cardiologists," researchers reported (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000424500.73199.04]).

The incidence of gastrointestinal bleeding with the drug in their study was 10.5%, higher than the 6.1% rate for any gastrointestinal bleeding stated in the package insert, Dr. Perry said in an interview.

In addition, pharmacists needed to correct the dabigatran dose in 24% of patients, and dabigatran had noticeable effects on clotting parameters, with 74% of patients having an activated partial thromboplastin time (aPTT) above the upper limit of normal, and 64% of patients having an international normalized ratio (INR) above the upper limit.

This finding suggests that in these patients, the clotting assays "may be useful to determine medication adherence but not to determine the level of anticoagulation," the authors wrote in a poster presentation.

"Clinicians need to be aware of the appropriate indication for use and renal dosing of dabigatran to prevent patient harm, as only 87% of patients were prescribed dabigatran for the FDA-labeled indication," they noted.

Major heparin boost needed

In a separate study, Dr. Thomas Edrich from the department of anesthesiology, perioperative and pain medicine at Brigham & Women’s Hospital in Boston and his colleagues found that for patients scheduled for catheter-based atrial ablation procedures, those who were on dabigatran required an approximately 50% greater dose of heparin to achieve full anticoagulation for the procedure than did patients on warfarin (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000425177.10736.a4]).

Patients who had been on warfarin until 12 hours before the procedure required about 3,000-4,000 IU of heparin/hr to achieve an activated clotting time of 350 seconds, compared with about 6,500-9,000 IU/hr in patients on dabigatran, Dr. Edrich said. They studied retrospective data for 36 patients on dabigatran, 100 patients on warfarin (53 with an INR above 2.0), and 29 patients on no anticoagulation.

"The interesting finding here is that if you’ve been on dabigatran, you’re going to need twice as much heparin," he said in a poster discussion session.

Patients like it, surgeons don’t

Although patients like the convenience of oral dosing without the need for regular INR monitoring with the new anticoagulants, often they are not told that convenience may come at a very high price if there is no effective therapy to reverse the anticoagulation effect, commented Dr. Christine Toevs, a critical care surgeon at the West Penn Allegheny Health System in Pittsburgh.

"The problem is that patients aren\'t informed enough to make that choice. They understand that they’re not getting their labs drawn once a week or twice a week, and they understand that’s not a cost that they are paying. But if they fall and they have a head injury, that is a life lost, and we cannot stop it," she said during a debate on the costs of new medications.

Dr. Perry’s and Dr. Edrich’s studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.

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oral anticoagulant dabigatran, Pradaxa, thrombin inhibitor, stroke, systemic embolism, nonvalvular atrial fibrillation, Coumadin/warfarin, Society of Critical Care Medicine, Dr. Trevor Perry, Dr. Harminder Sikand, gastrointestinal bleeding, pharmacists,
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Vitals

Major finding: Of 38 patients prescribed dabigatran during their hospital stay, 5 (13%) received it for unlabeled indications.

Data source: A prospective drug evaluation study of 38 patients; a retrospective study of 189 patients scheduled for catheter ablation of atrial fibrillation.

Disclosures: Dr. Perry's and Dr. Edrich's studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.

Tracheostomy collar yields faster long-term ventilation weaning

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Tracheostomy collar yields faster long-term ventilation weaning

SAN JUAN, P.R. – Patients on prolonged ventilation who had previously failed a 5-day breathing challenge were weaned more rapidly off ventilators when a tracheostomy collar rather than pressure support was used, Dr. Amal Jubran reported.

Among 312 patients on prolonged ventilation (more than 21 days) transferred to a long-term acute care hospital, the median weaning time with unassisted breathing through tracheostomy collars was 4 days shorter than when pressure support was used as the weaning method, said Dr. Jubran of the division of pulmonary and critical care medicine at the Edward Hines Jr. VA Hospital in Hines, Ill.

"The method of ventilator weaning significantly improves the outcome of patients who require prolonged ventilation ... at a long-term care facility," she said at the annual congress of the Society of Critical Care Medicine.

The study findings were published simultaneously online in JAMA. There, the authors suggested that the more rapid weaning achieved with the use of the tracheostomy collar could be because the collar allows clinicians to directly observe whether patients are capable of breathing spontaneously (JAMA 2013 [doi:10.1001/jama.2013.159]).

"During a tracheostomy collar challenge, the amount of respiratory effort is determined solely by the patient. As such, observing a patient breathing through a tracheostomy collar provides the clinician with a clear view of the patient’s respiratory capabilities. In contrast, a clinician’s ability to judge weanability during pressure support is clouded because the patient is receiving ventilator assistance," the investigators wrote.

Clinicians may be more willing to wean patients who do better than expected on a trachesotomy challenge than they would patients who are on only low levels of pressure support, the authors suggested.

Weaning failures randomized

They based their conclusions on a decade-long randomized trial of patients with tracheotomies on prolonged ventilation who were transferred to a single center for weaning.

A total of 500 patients had a 5-day screening process during which they were given humidified oxygen through a tracheostomy collar and observed for signs of respiratory distress. Patients with no signs of distress during the challenge were considered to be weaned from ventilation and were excluded from the study, and the remaining 316 were randomly assigned to weaning with either a tracheostomy collar or pressure support. Patients in each study arm were stratified into one of four underlying disease categories, and to either early- or late-failure groups, based on the time it took for the breathing trial to fail (0 to less than 12 hours for early failures, 12-120 hours for late failures).

Ultimately, a total of 312 patients were included in the analysis.

Of the 160 patients in the tracheostomy collar group, 15 were deemed to be unweanable, 15 withdrew for various reasons, 16 died, and 10 were transferred to an acute care hospital. Of the remaining 104 patients in this arm, 85 (53.1% of the total group) were successfully weaned.

Of the 152 patients in the pressure support group, 21 were judged to be unweanable, 12 withdrew, 7 were transferred to an acute care hospital, and 22 died. Of the remaining 90 patients, 68 (45% of the total) were successfully weaned.

The median weaning time for patients on the collar was 15 (interquartile range [IQR], 8-25 days), compared with 19 days (IQR, 12-31 days) for patients on pressure support.

In an analysis adjusted for baseline clinical covariates, the hazard ratio (HR) favoring tracheostomy collar weaning was 1.43. Among patients in the late-failure subgroup, tracheostomy offered significantly more rapid weaning than did pressure support (HR, 3.33). There was no significant difference between the methods in time to weaning among patients who were deemed to be early screening failures, however. There were also no significant differences between weaning protocols in either 6- or 12-month mortality rates.

Dr. Jubran and colleagues acknowledged that their study was limited by the inability to fully mask treatment type from investigators (although investigators analyzing the data were blinded to protocol assignment), and by the use of single-center data, potentially limiting generalizability.

The study was supported by funding from the National Institute of Nursing Research. Dr. Jubran reported having no relevant financial disclosures.

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SAN JUAN, P.R. – Patients on prolonged ventilation who had previously failed a 5-day breathing challenge were weaned more rapidly off ventilators when a tracheostomy collar rather than pressure support was used, Dr. Amal Jubran reported.

Among 312 patients on prolonged ventilation (more than 21 days) transferred to a long-term acute care hospital, the median weaning time with unassisted breathing through tracheostomy collars was 4 days shorter than when pressure support was used as the weaning method, said Dr. Jubran of the division of pulmonary and critical care medicine at the Edward Hines Jr. VA Hospital in Hines, Ill.

"The method of ventilator weaning significantly improves the outcome of patients who require prolonged ventilation ... at a long-term care facility," she said at the annual congress of the Society of Critical Care Medicine.

The study findings were published simultaneously online in JAMA. There, the authors suggested that the more rapid weaning achieved with the use of the tracheostomy collar could be because the collar allows clinicians to directly observe whether patients are capable of breathing spontaneously (JAMA 2013 [doi:10.1001/jama.2013.159]).

"During a tracheostomy collar challenge, the amount of respiratory effort is determined solely by the patient. As such, observing a patient breathing through a tracheostomy collar provides the clinician with a clear view of the patient’s respiratory capabilities. In contrast, a clinician’s ability to judge weanability during pressure support is clouded because the patient is receiving ventilator assistance," the investigators wrote.

Clinicians may be more willing to wean patients who do better than expected on a trachesotomy challenge than they would patients who are on only low levels of pressure support, the authors suggested.

Weaning failures randomized

They based their conclusions on a decade-long randomized trial of patients with tracheotomies on prolonged ventilation who were transferred to a single center for weaning.

A total of 500 patients had a 5-day screening process during which they were given humidified oxygen through a tracheostomy collar and observed for signs of respiratory distress. Patients with no signs of distress during the challenge were considered to be weaned from ventilation and were excluded from the study, and the remaining 316 were randomly assigned to weaning with either a tracheostomy collar or pressure support. Patients in each study arm were stratified into one of four underlying disease categories, and to either early- or late-failure groups, based on the time it took for the breathing trial to fail (0 to less than 12 hours for early failures, 12-120 hours for late failures).

Ultimately, a total of 312 patients were included in the analysis.

Of the 160 patients in the tracheostomy collar group, 15 were deemed to be unweanable, 15 withdrew for various reasons, 16 died, and 10 were transferred to an acute care hospital. Of the remaining 104 patients in this arm, 85 (53.1% of the total group) were successfully weaned.

Of the 152 patients in the pressure support group, 21 were judged to be unweanable, 12 withdrew, 7 were transferred to an acute care hospital, and 22 died. Of the remaining 90 patients, 68 (45% of the total) were successfully weaned.

The median weaning time for patients on the collar was 15 (interquartile range [IQR], 8-25 days), compared with 19 days (IQR, 12-31 days) for patients on pressure support.

In an analysis adjusted for baseline clinical covariates, the hazard ratio (HR) favoring tracheostomy collar weaning was 1.43. Among patients in the late-failure subgroup, tracheostomy offered significantly more rapid weaning than did pressure support (HR, 3.33). There was no significant difference between the methods in time to weaning among patients who were deemed to be early screening failures, however. There were also no significant differences between weaning protocols in either 6- or 12-month mortality rates.

Dr. Jubran and colleagues acknowledged that their study was limited by the inability to fully mask treatment type from investigators (although investigators analyzing the data were blinded to protocol assignment), and by the use of single-center data, potentially limiting generalizability.

The study was supported by funding from the National Institute of Nursing Research. Dr. Jubran reported having no relevant financial disclosures.

SAN JUAN, P.R. – Patients on prolonged ventilation who had previously failed a 5-day breathing challenge were weaned more rapidly off ventilators when a tracheostomy collar rather than pressure support was used, Dr. Amal Jubran reported.

Among 312 patients on prolonged ventilation (more than 21 days) transferred to a long-term acute care hospital, the median weaning time with unassisted breathing through tracheostomy collars was 4 days shorter than when pressure support was used as the weaning method, said Dr. Jubran of the division of pulmonary and critical care medicine at the Edward Hines Jr. VA Hospital in Hines, Ill.

"The method of ventilator weaning significantly improves the outcome of patients who require prolonged ventilation ... at a long-term care facility," she said at the annual congress of the Society of Critical Care Medicine.

The study findings were published simultaneously online in JAMA. There, the authors suggested that the more rapid weaning achieved with the use of the tracheostomy collar could be because the collar allows clinicians to directly observe whether patients are capable of breathing spontaneously (JAMA 2013 [doi:10.1001/jama.2013.159]).

"During a tracheostomy collar challenge, the amount of respiratory effort is determined solely by the patient. As such, observing a patient breathing through a tracheostomy collar provides the clinician with a clear view of the patient’s respiratory capabilities. In contrast, a clinician’s ability to judge weanability during pressure support is clouded because the patient is receiving ventilator assistance," the investigators wrote.

Clinicians may be more willing to wean patients who do better than expected on a trachesotomy challenge than they would patients who are on only low levels of pressure support, the authors suggested.

Weaning failures randomized

They based their conclusions on a decade-long randomized trial of patients with tracheotomies on prolonged ventilation who were transferred to a single center for weaning.

A total of 500 patients had a 5-day screening process during which they were given humidified oxygen through a tracheostomy collar and observed for signs of respiratory distress. Patients with no signs of distress during the challenge were considered to be weaned from ventilation and were excluded from the study, and the remaining 316 were randomly assigned to weaning with either a tracheostomy collar or pressure support. Patients in each study arm were stratified into one of four underlying disease categories, and to either early- or late-failure groups, based on the time it took for the breathing trial to fail (0 to less than 12 hours for early failures, 12-120 hours for late failures).

Ultimately, a total of 312 patients were included in the analysis.

Of the 160 patients in the tracheostomy collar group, 15 were deemed to be unweanable, 15 withdrew for various reasons, 16 died, and 10 were transferred to an acute care hospital. Of the remaining 104 patients in this arm, 85 (53.1% of the total group) were successfully weaned.

Of the 152 patients in the pressure support group, 21 were judged to be unweanable, 12 withdrew, 7 were transferred to an acute care hospital, and 22 died. Of the remaining 90 patients, 68 (45% of the total) were successfully weaned.

The median weaning time for patients on the collar was 15 (interquartile range [IQR], 8-25 days), compared with 19 days (IQR, 12-31 days) for patients on pressure support.

In an analysis adjusted for baseline clinical covariates, the hazard ratio (HR) favoring tracheostomy collar weaning was 1.43. Among patients in the late-failure subgroup, tracheostomy offered significantly more rapid weaning than did pressure support (HR, 3.33). There was no significant difference between the methods in time to weaning among patients who were deemed to be early screening failures, however. There were also no significant differences between weaning protocols in either 6- or 12-month mortality rates.

Dr. Jubran and colleagues acknowledged that their study was limited by the inability to fully mask treatment type from investigators (although investigators analyzing the data were blinded to protocol assignment), and by the use of single-center data, potentially limiting generalizability.

The study was supported by funding from the National Institute of Nursing Research. Dr. Jubran reported having no relevant financial disclosures.

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Early-morning team evaluations slash CCU ventilator time, pneumonia

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SAN JUAN, P.R. – To extubate or to keep the patient on a ventilator? That is the question which, when answered by a respiratory therapy team before the next morning’s rounds began, halved the rate of ventilator-associated pneumonias and significantly decreased the time patients spent on ventilators in a surgical critical care unit, investigators reported at the annual Congress of the Society of Critical Care Medicine.

Previously, spontaneous breathing tests had occurred either during or after morning rounds, with extubations being left until sometime later in the day. Under the new protocol, however, respiratory therapists assigned exclusively to the surgical CCU conducted rounds three times daily, consulted with nurses and physicians, and performed spontaneous breathing tests as recommended under joint 2001 guidelines. Thus armed with the information, the multiprofessional team could make the final decision to extubate, and the extubation itself could occur at morning rounds, getting patients off the ventilator that much sooner, said Dr. Vijay Jayaraman, a resident in surgery at the Christiana Care Health System in Wilmington, Del.

Dr. Vijay Jayaraman

Under the new protocol, Dr. Jayaraman and his colleagues saw the rate of ventilator-associated pneumonia (VAP) events decline from 10.8/1,000 ventilator days before the protocol was implemented, to 5.3/1,000 afterward (P less than .05). The mean time to start a spontaneous breathing trial dropped from 2.67 to 1.77 days (P = .004), and the time to extubation was shortened by a full day, 4.47 to 3.43 days (P = .033). There was no difference in days spent in the CCU post extubation, days spent on the patient floor after the CCU stay, or hospital length of stay, Dr. Jayaraman reported.

"This was established in a CCU that was already fully functioning with an active care team. It just required some reorganization, and the most important thing is that the respiratory therapist can be empowered to help us and actively drive the spontaneous breathing test and extubation process," he commented.

Dr. Juliana Barr, who moderated the session at which Dr, Jayaraman presented his study, commented that although myriad other groups have published ventilator-weaning protocols incorporating respiratory therapists, she was not aware of any studies that had previously shown a reduction in VAP rates.

"That was a low-hanging fruit study waiting for someone to do it, and I’m glad that you came along and did that. Thank you," she told Dr. Jayaraman. Dr. Barr is the acting medical director of critical care at the VA Palo Alto (Calif.) Health Care System.

Dr. Juliana Barr

The respiratory team uses predetermined criteria in a coordinated process consisting of awakening patients, performing the spontaneous breathing test, and, whenever possible, making the decision to extubate either before or during rounds.

For the study, the authors prospectively collected data on 180 patients admitted to their 28-bed level 1 surgical CCU from July through December 2010, before the protocol was implemented, and in 219 patients admitted over the same months in 2011, after the protocol had been in place for 6 months.

Extubate when the time is right

In a separate study, investigators from Montefiore Medical Center and other New York City institutions looked at whether outcomes following extubations in the CCU differed according to the time of day.

They retrospectively studied records of 2,240 patients on mechanical ventilation in 1 of 5 CCUs, and found that there were no significant differences in either 24-hour or 72-hour reintubation rates or in morality between patients extubated during daytime hours or during the night.

"Our data provides evidence that nighttime extubation is itself not associated with elevated risk of reintubation or mortality. Patients should be extubated when weaning parameters are met, irrespective of time of day, with appropriate staffing and resources," Dr. Bryan R. Tischenkel said in a poster presentation. Dr. Tischenkel is an anesthesia resident at New York Presbyterian Hospital.

Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.

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SAN JUAN, P.R. – To extubate or to keep the patient on a ventilator? That is the question which, when answered by a respiratory therapy team before the next morning’s rounds began, halved the rate of ventilator-associated pneumonias and significantly decreased the time patients spent on ventilators in a surgical critical care unit, investigators reported at the annual Congress of the Society of Critical Care Medicine.

Previously, spontaneous breathing tests had occurred either during or after morning rounds, with extubations being left until sometime later in the day. Under the new protocol, however, respiratory therapists assigned exclusively to the surgical CCU conducted rounds three times daily, consulted with nurses and physicians, and performed spontaneous breathing tests as recommended under joint 2001 guidelines. Thus armed with the information, the multiprofessional team could make the final decision to extubate, and the extubation itself could occur at morning rounds, getting patients off the ventilator that much sooner, said Dr. Vijay Jayaraman, a resident in surgery at the Christiana Care Health System in Wilmington, Del.

Dr. Vijay Jayaraman

Under the new protocol, Dr. Jayaraman and his colleagues saw the rate of ventilator-associated pneumonia (VAP) events decline from 10.8/1,000 ventilator days before the protocol was implemented, to 5.3/1,000 afterward (P less than .05). The mean time to start a spontaneous breathing trial dropped from 2.67 to 1.77 days (P = .004), and the time to extubation was shortened by a full day, 4.47 to 3.43 days (P = .033). There was no difference in days spent in the CCU post extubation, days spent on the patient floor after the CCU stay, or hospital length of stay, Dr. Jayaraman reported.

"This was established in a CCU that was already fully functioning with an active care team. It just required some reorganization, and the most important thing is that the respiratory therapist can be empowered to help us and actively drive the spontaneous breathing test and extubation process," he commented.

Dr. Juliana Barr, who moderated the session at which Dr, Jayaraman presented his study, commented that although myriad other groups have published ventilator-weaning protocols incorporating respiratory therapists, she was not aware of any studies that had previously shown a reduction in VAP rates.

"That was a low-hanging fruit study waiting for someone to do it, and I’m glad that you came along and did that. Thank you," she told Dr. Jayaraman. Dr. Barr is the acting medical director of critical care at the VA Palo Alto (Calif.) Health Care System.

Dr. Juliana Barr

The respiratory team uses predetermined criteria in a coordinated process consisting of awakening patients, performing the spontaneous breathing test, and, whenever possible, making the decision to extubate either before or during rounds.

For the study, the authors prospectively collected data on 180 patients admitted to their 28-bed level 1 surgical CCU from July through December 2010, before the protocol was implemented, and in 219 patients admitted over the same months in 2011, after the protocol had been in place for 6 months.

Extubate when the time is right

In a separate study, investigators from Montefiore Medical Center and other New York City institutions looked at whether outcomes following extubations in the CCU differed according to the time of day.

They retrospectively studied records of 2,240 patients on mechanical ventilation in 1 of 5 CCUs, and found that there were no significant differences in either 24-hour or 72-hour reintubation rates or in morality between patients extubated during daytime hours or during the night.

"Our data provides evidence that nighttime extubation is itself not associated with elevated risk of reintubation or mortality. Patients should be extubated when weaning parameters are met, irrespective of time of day, with appropriate staffing and resources," Dr. Bryan R. Tischenkel said in a poster presentation. Dr. Tischenkel is an anesthesia resident at New York Presbyterian Hospital.

Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.

SAN JUAN, P.R. – To extubate or to keep the patient on a ventilator? That is the question which, when answered by a respiratory therapy team before the next morning’s rounds began, halved the rate of ventilator-associated pneumonias and significantly decreased the time patients spent on ventilators in a surgical critical care unit, investigators reported at the annual Congress of the Society of Critical Care Medicine.

Previously, spontaneous breathing tests had occurred either during or after morning rounds, with extubations being left until sometime later in the day. Under the new protocol, however, respiratory therapists assigned exclusively to the surgical CCU conducted rounds three times daily, consulted with nurses and physicians, and performed spontaneous breathing tests as recommended under joint 2001 guidelines. Thus armed with the information, the multiprofessional team could make the final decision to extubate, and the extubation itself could occur at morning rounds, getting patients off the ventilator that much sooner, said Dr. Vijay Jayaraman, a resident in surgery at the Christiana Care Health System in Wilmington, Del.

Dr. Vijay Jayaraman

Under the new protocol, Dr. Jayaraman and his colleagues saw the rate of ventilator-associated pneumonia (VAP) events decline from 10.8/1,000 ventilator days before the protocol was implemented, to 5.3/1,000 afterward (P less than .05). The mean time to start a spontaneous breathing trial dropped from 2.67 to 1.77 days (P = .004), and the time to extubation was shortened by a full day, 4.47 to 3.43 days (P = .033). There was no difference in days spent in the CCU post extubation, days spent on the patient floor after the CCU stay, or hospital length of stay, Dr. Jayaraman reported.

"This was established in a CCU that was already fully functioning with an active care team. It just required some reorganization, and the most important thing is that the respiratory therapist can be empowered to help us and actively drive the spontaneous breathing test and extubation process," he commented.

Dr. Juliana Barr, who moderated the session at which Dr, Jayaraman presented his study, commented that although myriad other groups have published ventilator-weaning protocols incorporating respiratory therapists, she was not aware of any studies that had previously shown a reduction in VAP rates.

"That was a low-hanging fruit study waiting for someone to do it, and I’m glad that you came along and did that. Thank you," she told Dr. Jayaraman. Dr. Barr is the acting medical director of critical care at the VA Palo Alto (Calif.) Health Care System.

Dr. Juliana Barr

The respiratory team uses predetermined criteria in a coordinated process consisting of awakening patients, performing the spontaneous breathing test, and, whenever possible, making the decision to extubate either before or during rounds.

For the study, the authors prospectively collected data on 180 patients admitted to their 28-bed level 1 surgical CCU from July through December 2010, before the protocol was implemented, and in 219 patients admitted over the same months in 2011, after the protocol had been in place for 6 months.

Extubate when the time is right

In a separate study, investigators from Montefiore Medical Center and other New York City institutions looked at whether outcomes following extubations in the CCU differed according to the time of day.

They retrospectively studied records of 2,240 patients on mechanical ventilation in 1 of 5 CCUs, and found that there were no significant differences in either 24-hour or 72-hour reintubation rates or in morality between patients extubated during daytime hours or during the night.

"Our data provides evidence that nighttime extubation is itself not associated with elevated risk of reintubation or mortality. Patients should be extubated when weaning parameters are met, irrespective of time of day, with appropriate staffing and resources," Dr. Bryan R. Tischenkel said in a poster presentation. Dr. Tischenkel is an anesthesia resident at New York Presbyterian Hospital.

Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.

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Major finding: Ventilator-associated pneumonia event rates dropped from 10.8 to 5.3/1,000 ventilator days when evaluations for patient extubation were performed before morning rounds.

Data source: A prospective study of 399 patients treated in a 28-bed CCU in Delaware; a retrospective study of records on 2,240 patients treated in five CCUs in New York City hospitals.

Disclosures: Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.

ICU infection prevention: Trust protocols, but verify compliance

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ICU infection prevention: Trust protocols, but verify compliance

A healthy percentage of the morbidity, mortality, and costs associated with infections acquired in intensive care units are preventable by just following the rules, investigators said at the annual congress of the Society of Critical Care Medicine.

Interventions such as strict hand hygiene, meticulous attention to preinsertion disinfection of the patient’s skin, and the use of sterile dressings and drapes can dramatically reduce the incidence of catheter-related bloodstream infections (CRBSIs). Ventilator-associated pneumonia (VAP) can be prevented with precautions to avoid aspiration, reduction of upper airway colonization, and attention to sterilization of ventilatory equipment, said Dr. Alfred F. Connors Jr., senior associate dean of Case Western Reserve University, Cleveland.

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Dr. Alfred F. Connors, Jr.

"These are two areas where we are at a really important turning point, where we can really make a difference and change the incidence of these infections in our patients," he said.

The key to making it all work is ensuring that staff adhere to best practices, said investigators from Sutter General Hospital in Sacramento. They reported that a physician-led multidisciplinary team charged with monitoring adherence to VAP prevention guidelines reduced the incidence of ventilator-associated infections from 17 out of 3,173 ventilator-days in 2004, to 2 in 12,694 ventilator-days from 2008 to 2011, a statistically significant reduction.

Protocols yes, compliance maybe

Dr. Connors noted that in a cross-sectional survey of 415 ICUs in 250 hospitals with a mean of 2.7 VAP infections per 1,000 ventilator-days, 68% of hospitals had a VAP bundle policy in place, but only 45% monitored compliance, and only 18% reported high compliance with the policy (Int. J. Qual. Health Care 2011;23:538-44).

"Unless you have a policy, you’re monitoring it, and you’re demonstrating high compliance, you won’t show any effect on your ventilator-associated pneumonia rate. There’s no magic to this. You can’t just say ‘Okay, we’ve got a policy, please follow it,’ and expect ventilator-associated pneumonia rates to drop; we have to intervene actively to get high compliance, and that’s easier said than done," he said.

At MetroHealth system in Cleveland, where Dr. Connors is chief medical officer, instituting and enforcing a stepped-up hand-hygiene program, isolation procedures, enhanced environmental cleaning, antibiotic stewardship, and implementation of evidence-based protocols for prevention of VAP, CRBSIs, and catheter-associated urinary tract infections resulted in an 18% decrease in antibiotic days of therapy from 2009 through the third quarter of 2012, and 32% decreases in both VAP and CRBSIs from 2010 to 2012.

More importantly, Dr. Connors said, such efforts save both lives and costs. He pointed to a 2011 study of national data on hospital-associated infections, which found that with proper infection control procedures, an estimated 44,762 to 164,127 central line–associated bloodstream infection (CLABSI) cases could be prevented, translating into 5,520 to 20,239 lives saved, and an estimated 95,078 to 137,613 preventable VAP cases, equivalent to 13,667 to 19,782 lives saved (Infect. Control Hosp. Epidemiol. 2011;32:101-14).

Team rounding cuts VAP

Dr. Saman Hayatdavoudi and colleagues at Sutter General Hospital made major inroads into reducing VAP rates through the creation of a multidisciplinary rounding team consisting of an intensivist, acute-care nurse practitioner (ACNP), respiratory therapist, clinical pharmacist, and bedside nurses.

The team made daily clinical rounds to verify whether clinicians were complying with hospital protocols and adhering to ventilator bundles, backed by a checklist.

"When deficiencies were noted, the ACNP was authorized to write orders bringing the care plans into best practice compliance," they wrote in a poster presentation.

As noted before, the team intervention reduced the incidence of VAP substantially, to just 2 per 12,694 ventilator-days, well below the benchmark of the 5.1 per 1,000 ventilator-days established by the Centers for Disease Control and Prevention’s National Healthcare Safety Network.

Dr. Connors reported having no financial disclosures. The study by Dr. Hayatdavoudi and colleagues was internally funded. The authors reported having no financial disclosures

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A healthy percentage of the morbidity, mortality, and costs associated with infections acquired in intensive care units are preventable by just following the rules, investigators said at the annual congress of the Society of Critical Care Medicine.

Interventions such as strict hand hygiene, meticulous attention to preinsertion disinfection of the patient’s skin, and the use of sterile dressings and drapes can dramatically reduce the incidence of catheter-related bloodstream infections (CRBSIs). Ventilator-associated pneumonia (VAP) can be prevented with precautions to avoid aspiration, reduction of upper airway colonization, and attention to sterilization of ventilatory equipment, said Dr. Alfred F. Connors Jr., senior associate dean of Case Western Reserve University, Cleveland.

Neil Osterweil/IMNG Medical Media
Dr. Alfred F. Connors, Jr.

"These are two areas where we are at a really important turning point, where we can really make a difference and change the incidence of these infections in our patients," he said.

The key to making it all work is ensuring that staff adhere to best practices, said investigators from Sutter General Hospital in Sacramento. They reported that a physician-led multidisciplinary team charged with monitoring adherence to VAP prevention guidelines reduced the incidence of ventilator-associated infections from 17 out of 3,173 ventilator-days in 2004, to 2 in 12,694 ventilator-days from 2008 to 2011, a statistically significant reduction.

Protocols yes, compliance maybe

Dr. Connors noted that in a cross-sectional survey of 415 ICUs in 250 hospitals with a mean of 2.7 VAP infections per 1,000 ventilator-days, 68% of hospitals had a VAP bundle policy in place, but only 45% monitored compliance, and only 18% reported high compliance with the policy (Int. J. Qual. Health Care 2011;23:538-44).

"Unless you have a policy, you’re monitoring it, and you’re demonstrating high compliance, you won’t show any effect on your ventilator-associated pneumonia rate. There’s no magic to this. You can’t just say ‘Okay, we’ve got a policy, please follow it,’ and expect ventilator-associated pneumonia rates to drop; we have to intervene actively to get high compliance, and that’s easier said than done," he said.

At MetroHealth system in Cleveland, where Dr. Connors is chief medical officer, instituting and enforcing a stepped-up hand-hygiene program, isolation procedures, enhanced environmental cleaning, antibiotic stewardship, and implementation of evidence-based protocols for prevention of VAP, CRBSIs, and catheter-associated urinary tract infections resulted in an 18% decrease in antibiotic days of therapy from 2009 through the third quarter of 2012, and 32% decreases in both VAP and CRBSIs from 2010 to 2012.

More importantly, Dr. Connors said, such efforts save both lives and costs. He pointed to a 2011 study of national data on hospital-associated infections, which found that with proper infection control procedures, an estimated 44,762 to 164,127 central line–associated bloodstream infection (CLABSI) cases could be prevented, translating into 5,520 to 20,239 lives saved, and an estimated 95,078 to 137,613 preventable VAP cases, equivalent to 13,667 to 19,782 lives saved (Infect. Control Hosp. Epidemiol. 2011;32:101-14).

Team rounding cuts VAP

Dr. Saman Hayatdavoudi and colleagues at Sutter General Hospital made major inroads into reducing VAP rates through the creation of a multidisciplinary rounding team consisting of an intensivist, acute-care nurse practitioner (ACNP), respiratory therapist, clinical pharmacist, and bedside nurses.

The team made daily clinical rounds to verify whether clinicians were complying with hospital protocols and adhering to ventilator bundles, backed by a checklist.

"When deficiencies were noted, the ACNP was authorized to write orders bringing the care plans into best practice compliance," they wrote in a poster presentation.

As noted before, the team intervention reduced the incidence of VAP substantially, to just 2 per 12,694 ventilator-days, well below the benchmark of the 5.1 per 1,000 ventilator-days established by the Centers for Disease Control and Prevention’s National Healthcare Safety Network.

Dr. Connors reported having no financial disclosures. The study by Dr. Hayatdavoudi and colleagues was internally funded. The authors reported having no financial disclosures

A healthy percentage of the morbidity, mortality, and costs associated with infections acquired in intensive care units are preventable by just following the rules, investigators said at the annual congress of the Society of Critical Care Medicine.

Interventions such as strict hand hygiene, meticulous attention to preinsertion disinfection of the patient’s skin, and the use of sterile dressings and drapes can dramatically reduce the incidence of catheter-related bloodstream infections (CRBSIs). Ventilator-associated pneumonia (VAP) can be prevented with precautions to avoid aspiration, reduction of upper airway colonization, and attention to sterilization of ventilatory equipment, said Dr. Alfred F. Connors Jr., senior associate dean of Case Western Reserve University, Cleveland.

Neil Osterweil/IMNG Medical Media
Dr. Alfred F. Connors, Jr.

"These are two areas where we are at a really important turning point, where we can really make a difference and change the incidence of these infections in our patients," he said.

The key to making it all work is ensuring that staff adhere to best practices, said investigators from Sutter General Hospital in Sacramento. They reported that a physician-led multidisciplinary team charged with monitoring adherence to VAP prevention guidelines reduced the incidence of ventilator-associated infections from 17 out of 3,173 ventilator-days in 2004, to 2 in 12,694 ventilator-days from 2008 to 2011, a statistically significant reduction.

Protocols yes, compliance maybe

Dr. Connors noted that in a cross-sectional survey of 415 ICUs in 250 hospitals with a mean of 2.7 VAP infections per 1,000 ventilator-days, 68% of hospitals had a VAP bundle policy in place, but only 45% monitored compliance, and only 18% reported high compliance with the policy (Int. J. Qual. Health Care 2011;23:538-44).

"Unless you have a policy, you’re monitoring it, and you’re demonstrating high compliance, you won’t show any effect on your ventilator-associated pneumonia rate. There’s no magic to this. You can’t just say ‘Okay, we’ve got a policy, please follow it,’ and expect ventilator-associated pneumonia rates to drop; we have to intervene actively to get high compliance, and that’s easier said than done," he said.

At MetroHealth system in Cleveland, where Dr. Connors is chief medical officer, instituting and enforcing a stepped-up hand-hygiene program, isolation procedures, enhanced environmental cleaning, antibiotic stewardship, and implementation of evidence-based protocols for prevention of VAP, CRBSIs, and catheter-associated urinary tract infections resulted in an 18% decrease in antibiotic days of therapy from 2009 through the third quarter of 2012, and 32% decreases in both VAP and CRBSIs from 2010 to 2012.

More importantly, Dr. Connors said, such efforts save both lives and costs. He pointed to a 2011 study of national data on hospital-associated infections, which found that with proper infection control procedures, an estimated 44,762 to 164,127 central line–associated bloodstream infection (CLABSI) cases could be prevented, translating into 5,520 to 20,239 lives saved, and an estimated 95,078 to 137,613 preventable VAP cases, equivalent to 13,667 to 19,782 lives saved (Infect. Control Hosp. Epidemiol. 2011;32:101-14).

Team rounding cuts VAP

Dr. Saman Hayatdavoudi and colleagues at Sutter General Hospital made major inroads into reducing VAP rates through the creation of a multidisciplinary rounding team consisting of an intensivist, acute-care nurse practitioner (ACNP), respiratory therapist, clinical pharmacist, and bedside nurses.

The team made daily clinical rounds to verify whether clinicians were complying with hospital protocols and adhering to ventilator bundles, backed by a checklist.

"When deficiencies were noted, the ACNP was authorized to write orders bringing the care plans into best practice compliance," they wrote in a poster presentation.

As noted before, the team intervention reduced the incidence of VAP substantially, to just 2 per 12,694 ventilator-days, well below the benchmark of the 5.1 per 1,000 ventilator-days established by the Centers for Disease Control and Prevention’s National Healthcare Safety Network.

Dr. Connors reported having no financial disclosures. The study by Dr. Hayatdavoudi and colleagues was internally funded. The authors reported having no financial disclosures

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