Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial

Autor: Curley, Martha AQ, Wypij, David, Watson, R Scott, Grant, Mary Jo C, Asaro, Lisa A, Cheifetz, Ira M, Dodson, Brenda L, Franck, Linda S, Gedeit, Rainer G, Angus, Derek C, Matthay, Michael A, RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network
Rok vydání: 2015
Předmět:
Zdroj: JAMA, vol 313, iss 4
Popis: ImportanceProtocolized sedation improves clinical outcomes in critically ill adults, but its effect in children is unknown.ObjectiveTo determine whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care.Design, setting, and participantsCluster randomized trial conducted in 31 US pediatric intensive care units (PICUs). A total of 2449 children (mean age, 4.7 years; range, 2 weeks to 17 years) mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued, 28 days, or hospital discharge.InterventionIntervention PICUs (17 sites; n = 1225 patients) used a protocol that included targeted sedation, arousal assessments, extubation readiness testing, sedation adjustment every 8 hours, and sedation weaning. Control PICUs (14 sites; n = 1224 patients) managed sedation per usual care.Main outcomes and measuresThe primary outcome was duration of mechanical ventilation. Secondary outcomes included time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, neurological testing, PICU and hospital lengths of stay, in-hospital mortality, sedation-related adverse events, measures of sedative exposure (wakefulness, pain, and agitation), and occurrence of iatrogenic withdrawal.ResultsDuration of mechanical ventilation was not different between the 2 groups (intervention: median, 6.5 [IQR, 4.1-11.2] days; control: median, 6.5 [IQR, 3.7-12.1] days). Sedation-related adverse events including inadequate pain and sedation management, clinically significant iatrogenic withdrawal, and unplanned endotracheal tube/invasive line removal were not significantly different between the 2 groups. Intervention patients experienced more postextubation stridor (7% vs 4%; P = .03) and fewer stage 2 or worse immobility-related pressure ulcers (
Databáze: OpenAIRE