Sedation And Weaning in Children (SANDWICH)

Long title:

Sedation and weaning in children: a stepped wedge cluster randomised trial

Short title:


Chief Investigator:

Professor Bronagh Blackwood



Queen’s University Belfast


NIHR Health Technology Assessment Programme (HTA)

Lay Summary:

The optimal strategy for weaning infants and children from mechanical ventilation is uncertain. This pragmatic multi-centre, stepped-wedge, cluster randomised clinical trial of 18 pediatric intensive care units (PICUs) in the UK (Feb 2018 to Oct 2019). All invasively mechanically ventilated children were included unless they had a tracheostomy on admission or were not expected to survive to the next day. The intervention involved assessment of sedation level, daily screening for readiness to undertake a spontaneous breathing trial (SBT), a SBT to test ventilator liberation potential, and daily rounds to review sedation and readiness screening and set patient-relevant targets. The primary outcome was the duration of invasive mechanical ventilation. The treatment effect was a hazard ratio adjusted for calendar time and hospital site.
Patient characteristics, mortality and PICU length of stay were collected from the PICANet database.
A total of 8,843 patients completed the trial. Protocol intervention resulted in a significantly shorter median time to successful extubation (64.8 vs. 66.2 h, respectively; adjusted median difference, −6.1 h [interquartile range, −8.2 to −5.3 h]; adjusted hazard ratio, 1.11 [95% CI, 1.02 to 1.20]; P = 0.02). The incidence of serious adverse events was similar between groups.
Take home message: In infants and children requiring prolonged mechanical ventilation, use of a standardised sedation and ventilator liberation protocol was associated with a statistically significant but marginally clinically important reduction in time to first successful extubation.

Project Website:

Associated Publications:

BMJ Open. 2019
JAMA. 2021
Health Technol Assess. 2022
Nurs Crit Care. 2023