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      Long-Term Outcomes after Protocolized Sedation versus Usual Care in Ventilated Pediatric Patients


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          Rationale: Whether 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.

          Objectives: To compare postdischarge outcomes in children with acute respiratory failure cluster-randomized to a sedation protocol or usual care.

          Methods: A 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 Results: We 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.

          Conclusions: A 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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          Author and article information

          On behalf of : for the RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
          Am J Respir Crit Care Med
          Am. J. Respir. Crit. Care Med
          American Journal of Respiratory and Critical Care Medicine
          American Thoracic Society
          1 June 2018
          1 June 2018
          1 June 2018
          : 197
          : 11
          : 1457-1467
          [ 1 ]Department of Pediatrics, University of Washington, Seattle, Washington
          [ 2 ]Center for Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, Washington
          [ 3 ]Department of Cardiology and
          [ 12 ]Critical Care and Cardiovascular Program, Boston Children’s Hospital, Boston, Massachusetts
          [ 4 ]Department of Pediatrics, Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware
          [ 5 ]Division of Pediatric Critical Care, Ann & Robert H. Lurie Children’s Hospital, Chicago, Illinois
          [ 6 ]School of Nursing and
          [ 11 ]Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
          [ 7 ]Clinical Research, Investigation, and Systems Modeling of Acute Illness Center and
          [ 8 ]Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
          [ 9 ]Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts; and
          [ 10 ]Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
          Author notes
          Correspondence and requests for reprints should be addressed to Martha A. Q. Curley, R.N., Ph.D., University of Pennsylvania, Claire M. Fagin Hall, 418 Curie Boulevard, Office 425, Philadelphia, PA 19104-4217. E-mail: curley@ 123456nursing.upenn.edu .
          Author information
          PMC6005554 PMC6005554 6005554 201708-1768OC
          Copyright © 2018 by the American Thoracic Society
          : 30 August 2017
          : 08 January 2018
          Page count
          Figures: 1, Tables: 4, Pages: 11
          Original Articles
          Pediatric Critical Care

          post-traumatic stress disorder,health-related quality of life,functional status,respiratory failure,health care outcomes


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