• R Scott Watson, Lisa A Asaro, James H Hertzog, Lauren R Sorce, Alicia G Kachmar, Leslie A Dervan, Derek C Angus, David Wypij, CurleyMartha A QMAQ0000-0001-5228-669412 Critical Care and Cardiovascular Program, Boston Children's Hospital, Boston, Massachusetts.6 School of Nursing and.11 Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania., and RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network.
• 1 Department of Pediatrics, University of Washington, Seattle, Washington.
• Am. J. Respir. Crit. Care Med. 2018 Jun 1; 197 (11): 145714671457-1467.

RationaleWhether a nurse-implemented goal-directed sedation protocol resulting in more awake yet calm intubated children affects postdischarge functional status, health-related quality of life, or risk for post-traumatic stress disorder is unknown.ObjectivesTo compare postdischarge outcomes in children with acute respiratory failure cluster-randomized to a sedation protocol or usual care.MethodsA stratified random sample of 1,360 patients from 31 centers in the RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure) trial was assessed by mail, electronically, and/or telephone 6 months after ICU discharge. In treatment group comparisons, we controlled for age, baseline functional status, and severity of illness.Measurements And Main ResultsWe used the Pediatric Overall Performance Category and the Pediatric Cerebral Performance Category to characterize functional status, the Infant and Toddler Quality of Life Questionnaire (97-item full-length version) (<2 yr old) or Pediatric Quality of Life Inventory (≥2 yr old), and the Child Post-traumatic Stress Disorder Symptom Scale (≥8 yr old and developmentally able). Functional status worsened from baseline to follow-up in 20%. Decline in functional status did not differ by treatment arm and was more common among those with baseline impairment than those with baseline normal function (27 vs. 18%; P < 0.001). There were no significant differences in health-related quality of life total scores by treatment arm. Scores indicating risk of post-traumatic stress disorder occurred in 30%, with no difference between treatment arms.ConclusionsA sedation strategy that allows patients to be more awake and exposes them to fewer sedative and analgesic medications produces no long-term harm. However, postdischarge morbidity after acute respiratory failure is common. Clinical trial registered with www.clinicaltrials.gov (NCT00814099).

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