Sedation AND Weaning In Children (SANDWICH) : protocol for a cluster randomised stepped wedge trial.

Blackwood, B ORCID:, Agus, A, Boyle, R, Clarke, M, Hemming, Karla, Jordan, J, Macrae, D, McAuley, D, McDowell, C, McIlmurray, L, Morris, K, Murray, M, Parslow, R, Peters, M, Tume, LN ORCID: and Walsh, T 2019, 'Sedation AND Weaning In Children (SANDWICH) : protocol for a cluster randomised stepped wedge trial.' , BMJ Open, 9 , e031630.

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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 multi-component 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 eight-week baseline data collection period in all sites, one site will be randomly chosen to transition to the intervention every four weeks and will start an eight-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.

Item Type: Article
Schools: Schools > School of Health and Society > Centre for Health Sciences Research
Journal or Publication Title: BMJ Open
Publisher: BMJ Publishing Group
Related URLs:
Funders: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme
Depositing User: Dr Lyvonne Tume
Date Deposited: 15 Nov 2019 09:04
Last Modified: 16 Feb 2022 03:14

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