Effect of a Sedation and Ventilator Liberation Protocol vs Usual Care on Duration of Invasive Mechanical Ventilation in Pediatric Intensive Care Units

Abstract

IMPORTANCEThere is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit.OBJECTIVE To determine if a sedation and ventilator liberation protocol intervention reduces the duration of invasive mechanical ventilation in infants and children anticipated to require prolonged mechanical ventilation. DESIGN, SETTING, AND PARTICIPANTSA pragmatic multicenter, stepped-wedge, cluster randomized clinical trial was conducted that included 17 hospital sites (18 pediatric intensive care units) in the UK sequentially randomized from usual care to the protocol intervention. From February 2018 to October 2019, 8843 critically ill infants and 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 infants and children) or a sedation and ventilator liberation protocol intervention (n = 4688 infants and children) 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 MEASURESThe primary outcome was the duration of invasive mechanical ventilation from initiation of ventilation until the first successful extubation. The primary estimate of the treatment effect was a hazard ratio (with a 95% CI) adjusted for calendar time and cluster (hospital site) for infants and children anticipated to require prolonged mechanical ventilation. RESULTS There were a total of 8843 infants and children (median age, 8 months [interquartile range, 1 to 46 months]; 42% were female) who completed the trial. There was a significantly shorter median time to successful extubation for the protocol intervention compared with usual care (64.8 hours vs 66.2 hours, respectively; adjusted median difference, −6.1 hours [interquartile range, −8.2 to −5.3 hours]; adjusted hazard ratio, 1.11 [95% CI, 1.02 to 1.20], P = .02). The serious adverse event of hypoxia occurred in 9 (0.2%) infants and children for the protocol intervention vs 11 (0.3%) for usual care; nonvascular device dislodgement occurred in 2 (0.04%) vs 7 (0.1%), respectively.CONCLUSIONS AND RELEVANCE Among infants and children anticipated to require prolonged mechanical ventilation, a sedation and ventilator liberation protocol 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.

Ventilation Liberation Practices Among 380 International PICUs

“…Protocols driven by bedside providers may identify eligible patients earlier and result in improved clinical outcomes ( 5 , 6 , 8 ). Other PICU liberation initiatives that heavily relied on nonphysician members of the multidisciplinary have also shown safety and efficacy ( 10 , 23 , 24 ). In any improvement strategy, harnessing the skills of the multidisciplinary is likely to be critical.…”

Pain and sedation management and monitoring in pediatric intensive care units across Europe: an ESPNIC survey

“…Over the last 2 decades use of nurse-driven sedation protocols has been increasingly reported and evaluated [ 35 – 38 ]. A recently published study showed a significant reduction of time to successful extubation after implementation of a sedation and ventilator liberation protocol in 18 PICU sites [ 39 ]. However, its clinical importance may be questionable since the median time to extubation would only decrease from 66.2 to 64.8 h after the implementation of the protocol intervention.…”

Modified ABCDEF-Bundles for Critically Ill Pediatric Patients - What Could They Look Like?

“…Most importantly, they have emerged as an independent risk factor for the development of pediatric delirium ( 34 ). While not all studies show a reduction in length of mechanical ventilation after implementation of sedation protocols, they do show a decrease in days with pain, withdrawal or delirium ( 35 , 36 ). Use of sedation protocols has been shown to help in reducing use of benzodiazepines, support the interdisciplinary communication in order to set and manage goals of sedation and to lessen the presentation of iatrogenic withdrawal symptoms ( 37 ).…”