Ensuring the safety and comfort of critically ill infants or children supported on mechanical ventilation is integral to the practice of pediatric critical care. Humane pediatric intensive care often includes sedation management. Although there are clear benefits in using sedation in pediatric patients who are unable to understand the imperative nature of critical care instrumentation and immobility, sedative use is associated with iatrogenic injury. Specifically, the medications used for sedation may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Over time, drug tolerance develops and may precipitate iatrogenic withdrawal syndrome when sedation is no longer necessary. Prolonging the duration of mechanical ventilation and iatrogenic withdrawal syndrome add to the personal and financial burden of intensive care. This cluster randomized clinical trial will test an innovative approach to sedation management that includes: [a] team education and consensus on the use of sedatives in pediatric patients supported on mechanical ventilation, [b] team identification of the patient's trajectory of illness and daily prescription of a sedation goal, [c] a Nurse-Implemented Goal-Directed Comfort Algorithm that guides moment-to-moment titration of opioids and benzodiazepines, and [d] team feedback on sedation management performance. The intervention is an organizational change directed at all PICU clinicians. The unit of randomization is the PICU, the unit of inference is the patient, and we will control for center effects. Eighteen pediatric intensive care units (9 randomized to the sedation management intervention and 9 to continue to provide usual care) will enroll 2754 critically-ill infants and children supported on mechanical ventilation. We believe that patients managed per sedation protocol will experience fewer days of mechanical ventilation, less sedative exposure, fewer iatrogenic withdrawal symptoms, a shorter intensive care length of stay, less costs, and experience a better post-discharge quality of life and emotional health.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL086622-03
Application #
7793420
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Harabin, Andrea L
Project Start
2008-04-01
Project End
2013-03-31
Budget Start
2010-04-01
Budget End
2011-03-31
Support Year
3
Fiscal Year
2010
Total Cost
$3,103,892
Indirect Cost
Name
University of Pennsylvania
Department
Type
Schools of Nursing
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Schneider, James B; Sweberg, Todd; Asaro, Lisa A et al. (2017) Sedation Management in Children Supported on Extracorporeal Membrane Oxygenation for Acute Respiratory Failure. Crit Care Med 45:e1001-e1010
Upperman, Jeffrey S; Lacroix, Jacques; Curley, Martha A Q et al. (2017) Specific Etiologies Associated With the Multiple Organ Dysfunction Syndrome in Children: Part 1. Pediatr Crit Care Med 18:S50-S57
Weiss, Scott L; Asaro, Lisa A; Flori, Heidi R et al. (2017) Multiple Organ Dysfunction in Children Mechanically Ventilated for Acute Respiratory Failure. Pediatr Crit Care Med 18:319-329
Faustino, Edward Vincent; Gedeit, Rainer G; Schwarz, Adam et al. (2017) The authors reply. Crit Care Med 45:e333-e334
Lebet, Ruth; Hayakawa, Jennifer; Chamblee, Tracy B et al. (2017) Maintaining Interrater Agreement of Core Assessment Instruments in a Multisite Randomized Controlled Clinical Trial: The Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Trial. Nurs Res 66:323-329
Best, Kaitlin M; Wypij, David; Asaro, Lisa A et al. (2017) The authors reply. Crit Care Med 45:e623-e624
Faustino, Edward Vincent S; Gedeit, Rainer; Schwarz, Adam J et al. (2017) Accuracy of an Extubation Readiness Test in Predicting Successful Extubation in Children With Acute Respiratory Failure From Lower Respiratory Tract Disease. Crit Care Med 45:94-102
Best, Kaitlin M; Asaro, Lisa A; Franck, Linda S et al. (2016) Patterns of Sedation Weaning in Critically Ill Children Recovering From Acute Respiratory Failure. Pediatr Crit Care Med 17:19-29
Grant, Mary Jo C; Schneider, James B; Asaro, Lisa A et al. (2016) Dexmedetomidine Use in Critically Ill Children With Acute Respiratory Failure. Pediatr Crit Care Med 17:1131-1141
Curley, Martha A Q; Wypij, David; Watson, R Scott et al. (2015) Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 313:379-89

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