Tailored Sedation Fails to Cut Ventilator Time in Children

By Megan Brooks

January 21, 2015

NEW YORK (Reuters Health) - An individualized sedation protocol didn't lead to shorter time on mechanical ventilation in children with acute respiratory failure enrolled in a cluster randomized trial.

However, exploratory analyses of several secondary outcomes found that the sedation protocol was associated with a difference in patients' sedation experience.

Children in the intervention group were safely managed in a "more awake and calm state" while intubated. They were also exposed to fewer opioids and fewer sedative classes, with no higher rate of inadequate pain or sedation management or clinically significant withdrawal, compared to children receiving usual care.

But they had more days with "any report of pain and agitation, suggesting a complex relationship among wakefulness, pain, and agitation," the researchers say.

The study findings were published January 20 in JAMA to coincide with a presentation at the Society of Critical Care Medicine's 44th Critical Care Congress.

"Light sedation or no sedation has become the therapeutic goal in critically ill adults," Dr. Sangeeta Mehta of the Mount Sinai Hospital and University of Toronto, Ontario, Canada, notes in a linked editorial.

"Large randomized trials and systematic reviews have demonstrated that this goal is feasible, safe, and beneficial. The benefits include shorter durations of mechanical ventilation and stay in the intensive care unit (ICU). However, prospective data supporting the benefits of minimizing sedation in children are lacking," Dr. Mehta points out.

The trial, led by Dr. Martha Curley, the Ellen and Robert Kapito Professor in Nursing Science at the University of Pennsylvania School of Nursing, is the first to evaluate the use of a nurse-directed sedation protocol in children.

At 31 pediatric intensive care units (PICUs) in the U.S., children ages 2 weeks to 17 years who were on mechanical ventilation for acute respiratory failure were managed either with a protocol that included targeted sedation, arousal assessments, extubation readiness testing, and sedation titration every eight hours (17 intervention PICUs, 1225 children) or usual sedation care (14 control PICUs, 1224 patients).

There was no difference in the primary outcome of duration of mechanical ventilation (median 6.5 days in both), or in time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, PICU and hospital lengths of stay or 28- or 90-day in-hospital mortality.

Nor were there differences in sedation-related adverse events including inadequate pain management, inadequate sedation management, extubation failure, ventilator-associated pneumonia, catheter-associated bloodstream infection, or new tracheostomy.

Children on the sedation protocol experienced more postextubation stridor (7% vs 4%) but fewer stage 2 or worse immobility-related pressure ulcers (<1% vs 2%).

"We now know that targeting a sedation goal of patients who are calm, easily aroused, and readily evaluated is attainable and safe in children ventilated for acute respiratory failure," Dr. Curley said in email to Reuters Health. "PICU nurses, working within an interprofessional team, can safely manage the protocol and reduce unnecessary variation in care."

The findings might also help guide future trials, she said. "Sedation management, like so many critical care therapies, is managed within a multidisciplinary team. Successful execution of this study required medical, nursing, and pharmacy leadership at each of the 31 enrolling centers. This interprofessional template for team science can be applied in the future study of similar complex therapies," Dr. Curley said.

Dr. Mehta says the research team has "answered the call for the conduct of a large clinical trial in children and has contributed valuable data to help advance approaches to sedation management in critically ill children. While it is disappointing that this trial showed no advantage of a complex sedation management strategy, it is reassuring that the overall clinical outcomes related to 'usual care' in the 14 control PICUs were not significantly different than protocolized sedation in the intervention PICUs. It is imperative that high-quality research in this field continues, not only to learn more about the short- and long-term effects of sedation strategies but, more importantly, to improve clinical care and outcomes for these vulnerable patients," Dr. Mehta concludes.

This research was supported by the National Heart, Lung, and Blood Institute and the National Institute of Nursing Research, National Institutes of Health.

SOURCE: http://bit.ly/1sUV9Si and http://bit.ly/1xpsLUT

JAMA 2015.

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