The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric critical care, analgesic and sedative use in this patient population can be associated with iatrogenic injury; specifically, comfort medications may depress spontaneous ventilation and prolong the duration of weaning from mechanical ventilation. Additionally, drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome when the patient no longer requires sedation. Alternatively, suboptimal comfort management contributes to ventilator dysynchrony and unplanned endotracheal extubation. Our group has developed and validated a nurse-implemented sedation algorithm to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication, but this algorithm needs to be evaluated further. We will pilot test the sedation algorithm in a randomized controlled clinical trial of two matched pediatric intensive care units in two different hospitals. One hospital will be randomized to their usual standard practices for managing sedation, while the other will receive (a) multidisciplinary team education and consensus building, (b) multidisciplinary team identification of the patient's trajectory of illness and daily prescription of a sedation goal, (c) a nurse-implemented sedation algorithm to guide titration of comfort medications, and (d) team feedback on clinical performance. We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care. Secondary outcomes include time to recovery from acute lung injury, duration of weaning from mechanical ventilation, occurrence of adverse events, total exposure to comfort medications, occurrence of iatrogenic opioid and benzodiazepine withdrawal symptoms, PICU length of stay, barriers to successful implementation of the intervention and PICU costs. The overall objective of this study is to develop an intervention that can be implemented in any PICU that will provide comfort to intubated and mechanically ventilated infants and children that will not cause them harm. Results of this pilot study will be used to design a future multi-center randomized controlled clinical trial.
| 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 |
| Curley, Martha A Q (2012) Clinical research: together, stronger, bolder. Am J Crit Care 21:234-41 |
| Franck, Linda S; Harris, Sion Kim; Soetenga, Deborah J et al. (2008) The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med 9:573-80 |
| Curley, Martha A Q; Harris, Sion Kim; Fraser, Karen A et al. (2006) State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med 7:107-14 |
