Sedation, paralysis do not improve survival of ICU patients
Reversibly paralysing and heavily sedating hospitalized patients with severe breathing problems do not improve outcomes in most cases, according to a National Institutes of Health-funded clinical trial conducted at dozens of North American hospitals and led by clinician-scientists at the University of Pittsburgh and University of Colorado schools of medicine.
The trial—which was stopped early due to futility—settles a long-standing debate in the critical care medicine community about whether it is better to paralyse and sedate patients in acute respiratory distress to aid mechanical ventilation or avoid heavy sedation to improve recovery.
“It’s been a conundrum—on the one hand, really well-done studies have shown that temporarily paralysing the patient to improve mechanical breathing saves lives. But you can’t paralyse without heavy sedation, and studies also show heavy sedation results in worse recovery. You can’t have both—so what’s a clinician to do?” said senior author Derek Angus, M.D., M.P.H., who holds the Mitchell P. Fink Endowed Chair of the Pitt School of Medicine’s Department of Critical Care Medicine. “Our trial finally settles it—light sedation with intermittent, short-term paralysis if necessary is as good as deep sedation with continuous paralysis.”
The Re-evaluation Of Systemic Early neuromuscular blockade (ROSE) trial is the first of the new National Heart, Lung, and Blood Institute’s (NHLBI) Prevention & Early Treatment of Acute Lung Injury (PETAL) Network. PETAL develops and conducts randomized controlled clinical trials to prevent or treat patients who have, or who are at risk for, acute lung injury or acute respiratory distress syndrome. The trial network places particular emphasis on early detection by requiring every network member institute include both critical care and emergency medicine, acute care or trauma principal investigators to ensure that critical health issues are recognized and triaged as fast as possible to improve patients’ odds of recovery before they are even transferred to the intensive care unit.
Angus, who also directs Pitt’s Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, said the trial results make him confident when he says that avoiding paralysis and deep sedation is the best practice for most patients hospitalized with breathing problems. However, he notes that future trials will be needed to tease out whether there is a subpopulation of patients with acute respiratory distress syndrome who still benefit from neuromuscular blockade.