eprintid: 10086162 rev_number: 19 eprint_status: archive userid: 608 dir: disk0/10/08/61/62 datestamp: 2019-11-19 11:10:03 lastmod: 2021-12-13 02:01:55 status_changed: 2019-11-19 11:10:03 type: article metadata_visibility: show creators_name: Blackwood, B creators_name: Agus, A creators_name: Boyle, R creators_name: Clarke, M creators_name: Hemming, K creators_name: Jordan, J creators_name: Macrae, D creators_name: McAuley, DF creators_name: McDowell, C creators_name: McIlmurray, L creators_name: Morris, KP creators_name: Murray, M creators_name: Parslow, R creators_name: Peters, MJ creators_name: Tume, LN creators_name: Walsh, T creators_name: Paediatric Intensive Care Society Study Group (PICS-SG), title: Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial ispublished: pub divisions: UCL divisions: B02 divisions: D13 divisions: G24 keywords: clinical trial, intensive care, paediatric, stepped wedge, ventilator weaning note: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. 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. date: 2019-11-10 date_type: published official_url: https://doi.org/10.1136/bmjopen-2019-031630 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1719833 doi: 10.1136/bmjopen-2019-031630 pii: bmjopen-2019-031630 lyricists_name: Peters, Mark lyricists_id: MJPET74 actors_name: Peters, Mark actors_id: MJPET74 actors_role: owner full_text_status: public publication: BMJ Open volume: 9 number: 11 article_number: e031630 event_location: England issn: 2044-6055 citation: Blackwood, B; Agus, A; Boyle, R; Clarke, M; Hemming, K; Jordan, J; Macrae, D; ... Paediatric Intensive Care Society Study Group (PICS-SG); + view all <#> Blackwood, B; Agus, A; Boyle, R; Clarke, M; Hemming, K; Jordan, J; Macrae, D; McAuley, DF; McDowell, C; McIlmurray, L; Morris, KP; Murray, M; Parslow, R; Peters, MJ; Tume, LN; Walsh, T; Paediatric Intensive Care Society Study Group (PICS-SG); - view fewer <#> (2019) Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial. BMJ Open , 9 (11) , Article e031630. 10.1136/bmjopen-2019-031630 <https://doi.org/10.1136/bmjopen-2019-031630>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10086162/1/e031630.full.pdf