Article Text
Abstract
Introduction Weaning from ventilation is a complex process involving several stages that include recognition of patient readiness to begin the weaning process, steps to reduce ventilation while optimising sedation in order not to induce distress and removing the endotracheal tube. Delay at any stage can prolong the duration of mechanical ventilation. We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
Methods and analysis This is a 20-month cluster randomised stepped wedge clinical and cost-effectiveness trial with an internal pilot and a process evaluation. It is being conducted in 18 paediatric intensive care units in the UK to evaluate a protocol-based intervention for reducing the duration of invasive mechanical ventilation. Following an initial 8-week baseline data collection period in all sites, one site will be randomly chosen to transition to the intervention every 4 weeks and will start an 8-week training period after which it will continue the intervention for the remaining duration of the study. We aim to recruit approximately 10 000 patients. The primary analysis will compare data from before the training (control) with that from after the training (intervention) in each site. Full details of the analyses will be in the statistical analysis plan.
Ethics and dissemination This protocol was reviewed and approved by NRES Committee East Midlands—Nottingham 1 Research Ethics Committee (reference: 17/EM/0301). All sites started patient recruitment on 5 February 2018 before randomisation in April 2018. Results will be disseminated in 2020. The results will be presented at national and international conferences and published in peer-reviewed medical journals.
Trial registration number ISRCTN16998143.
- clinical trial
- intensive care
- paediatric
- stepped wedge
- ventilator weaning
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Footnotes
Contributors BB, AA, MC, KH, JJ, DM, DFMA, CMD, KM, MM, RB, RP, MJP, LNT and TW conceived the SANDWICH trial. BB led the grant application and, as Chief Investigator, has oversight for the trial. KH and CMD have oversight for the statistical analysis; AA has oversight for the economic analysis; LMI and TW designed the online training materials; JJ designed and conducted the process evaluation; and RB and MM managed the trial. BB drafted this manuscript, and all authors contributed to, read and approved the final version.
Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number: HTA—15/104/01). Queen’s University Belfast is the sponsor for the trial.
Disclaimer The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA Programme, NIHR, NHS, the Department of Health nor the sponsor.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The protocol (and amendments) received ethical approval from NRES Committee East Midlands—Nottingham 1 REC (17/EM/0301).
Provenance and peer review Not commissioned; externally peer reviewed.