Effect of a sedation and ventilator liberation protocol vs usual care on duration of invasive mechanical ventilation in pediatric intensive care
units : a randomized clinical trial

Blackwood, B; Tume, LN; Morris, K; Clarke, M; McDowall, C; Hemming, K; Peters, M; McMurray, L; Jordan, J; Agus, A; Murray, M; Parslow, R; Walsh, T; Macrae, D; Easter, C; Feltbower, R; McAuley, D

Abstract

Importance: There is limited evidence on the optimal strategy for liberating children from invasive mechanical ventilation in the pediatric intensive care unit.

Objective: To determine if a ventilator liberation intervention reduces duration of invasive mechanical ventilation in children anticipated to require prolonged mechanical ventilation.

Design, Setting, Participants: A pragmatic multi-center, stepped-wedge, cluster randomized trial. Seventeen hospital sites (18 pediatric intensive care units) in the United Kingdom were sequentially randomized from usual care to the intervention. From February 2018 to October 2019, 8843 critically ill children anticipated to require prolonged mechanical ventilation were recruited. The last date of follow-up was November 11, 2019.

Interventions: Pediatric intensive care units provided usual care (n = 4155 participants) or the sedation and ventilator liberation intervention (n = 4688 participants) that consisted of assessment of sedation level, daily screening for readiness to undertake a spontaneous breathing trial, a spontaneous breathing trial to test ventilator liberation potential, and daily rounds to review sedation and readiness screening and set patient-relevant targets.

Main outcomes and measures: The primary outcome was duration of invasive mechanical ventilation from initiation of ventilation until first successful extubation. The primary estimate of the treatment effect was a calendar time and cluster adjusted hazard ratio (aHR) with 95% confidence intervals (CI) in children anticipated to have prolonged mechanical ventilation.

Results: All 8843 children observed under intervention and usual care conditions (median age, 8 months; 42% female) completed the trial. The intervention compared with usual care resulted in a significantly shorter median time to successful extubation (64.8 vs 66.2, adjusted median [IQR] difference, -6.1 hours, [-8.2- -5.3]; aHR 1.11, 95% CI 1.02-1.20, P=0.02). Serious adverse events included hypoxia (intervention n=9, 0.2% vs usual care n=11, 0.3%) and nonvascular device dislodgement (intervention n=2, 0.04% vs usual care n=7, 0.1%).

Conclusions and relevance: Among children anticipated to have prolonged of mechanical ventilation, a sedation and ventilator liberation intervention compared with usual care resulted in a statistically significant reduction in time to first successful extubation. However, the clinical importance of the effect size is uncertain.

Trial registration: International Standard Randomised Controlled Trial Number ISRCTN16998143

Citation

units : a randomized clinical trial. Journal of the American Medical Association, 326(5), 401-410. https://doi.org/10.1001/jama.2021.10296

• Journal Article Type: Article
• Acceptance Date: Jun 5, 2021
• Publication Date: Aug 3, 2021
• Deposit Date: Aug 4, 2021
• Publicly Available Date: Feb 3, 2022
• Journal: The Journal of the American Medical Association (JAMA)
• Print ISSN: 0098-7484
• Electronic ISSN: 1538-3598
• Publisher: American Medical Association
• Volume: 326
• Issue: 5
• Pages: 401-410
• DOI: https://doi.org/10.1001/jama.2021.10296
• Publisher URL: https://doi.org/10.1001/jama.2021.10296
• Related Public URLs: http://jama.jamanetwork.com/