Lighter ventilator sedation protocol no better than usual care in the PICU

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Usual-care PICUs probably used lighter sedation, too

“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’s likely “patients in the control group also were managed with goal-directed minimal sedation despite the lack of a formal protocol. ... Pediatric clinicians are certainly aware of the benefits of goal-directed sedation and are likely practicing it.

“The algorithm used in the study was complex, potentially affecting adherence. ... Perhaps a simpler, less structured algorithm would have been associated with positive results.

“Another question is whether adjustment of sedative doses every 8 hours is adequate and whether more frequent titration would have resulted in lower sedative exposure in the intervention group. Deepest sedation [was] in the acute phase [with] progressive lightening of sedation as the patient approached extubation. However, deep sedation in the early phase of illness may not be necessary and may be detrimental. ... It is possible that the intervention group was adversely affected by the deep sedation.”

Dr. Sangeeta Mehta is a critical care physician and respirologist at Mount Sinai Hospital in Toronto. She had no conflicts of interest, and wrote this editorial in response to Dr. Curley’s article (JAMA 2015 [doi:10.1001/jama.2015.1]).




PHOENIX – A pediatric ICU protocol to minimize sedation during intubation did not reduce ventilator days among children with acute respiratory failure, compared with usual care, in a randomized trial of 2,449 children across 31 ICUs.

The results were published online Jan. 20 in JAMA.

Seventeen pediatric ICUs (PICUs) followed a protocol that included sedation adjustment at least every 8 hours based on phase of illness; arousal assessments during titration and weaning; daily extubation readiness testing when spontaneously breathing; and weaning off opioids and benzodiazepines if patients were on them for 5 or more days, instead of simply discontinuing them.

The 1,225 children on the protocol were ventilated a median of 6.5 days, the same length as the 1,224 children in the 14 usual-care PICUs. There were no differences in sedation-related adverse events, including inadequate pain and sedation control, clinically significant drug withdrawal symptoms, and unplanned endotracheal tube removal (JAMA 2015 [doi:10.1001/jama.2014.18399])

It’s become clear in recent years that intubated adults do better with lighter sedation, and the PICU findings don’t necessarily mean that children are somehow different. A more likely explanation of the findings is that the control PICUs were using a lighter touch, too; prior to randomization, all the PICUs implemented the same pain, sedation, and withdrawal scales.

In any case, the study does show that “targeting a sedation goal of patients who are calm, easily aroused, and readily evaluated is attainable and safe in children,” wrote registered nurse Martha Curley, Ph.D., of the University of Pennsylvania, Philadelphia, and her associates . The study results were published to coincide with Dr. Curley’s presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

The protocol patients had a median 9 days of opioids, versus 10 in the usual-care group, and they were awake and calm while intubated a median of 86% of days, versus 75% in the control group. However, intervention children had pain during about half of their days, while usual-care children reported pain during about quarter of their days. Intervention patients also had more agitation, and postextubation stridor, but fewer pressure sores. There were no differences in mortality between the groups.

Morphine was the primary protocol opioid, while fentanyl was used most often in the control group. Morphine was selected for the protocol because it has a longer duration of action, plus some sedative properties and less development of tolerance. The primary sedative in both groups was midazolam; about a quarter of protocol patients received dexmedetomidine, versus about half in the usual-care group.

Baseline patient characteristics were well matched between the two groups, except that the intervention group enrolled more patients younger than 2 years and more patients with bronchiolitis, both of whom are harder to sedate. Pneumonia, bronchiolitis, and acute respiratory failure due to sepsis were the most common diagnoses in both groups. The mean age of the children was 4.7 years.

The work, dubbed the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study, was supported by grants from the National Heart, Lung, and Blood Institute and the National Institute of Nursing Research. The lead author had no disclosures. One coauthor is an advisor for Philips, and another reported consultant and other fees from Cerus, Quark Pharmaceuticals, Biogen, GlaxoSmithKline, and other companies.

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