@article{225d9e9ee3f448fab1eadb77b628a07c,
title = "Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial",
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.",
keywords = "Child, Cost-Benefit Analysis, Deep Sedation, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic/methods, Respiration, Artificial/statistics & numerical data, Ventilator Weaning/methods",
author = "Bronagh Blackwood and Ashley Agus and Roisin Boyle and Mike Clarke and Karla Hemming and Joanne Jordan and Duncan Macrae and McAuley, {Daniel Francis} and Cl{\'i}ona McDowell and Lisa McIlmurray and Morris, {Kevin P} and Margaret Murray and Roger Parslow and Peters, {Mark J} and Tume, {Lyvonne N} and Tim Walsh",
note = "{\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. Funding Information: We undertook consultation interviews with parents, a 15-year-old PICU survivor and 13 young people who were members of the National Institute for Health Research (NIHR) Clinical Research Network: Children, Young Person{\textquoteright}s Advisory Group about the proposed trial. Their views have contributed to the choice of patient relevant outcomes and informed the approach to consent. The consultation work was funded by the Northern Ireland Health and Social Care Research and Development Division and aided by Jenny Preston, Consumer Liaison Manager for the NIHR-Children Research Network. We secured patient and young people{\textquoteright}s continued involvement to provide advice on study design, implementation, parent and child information leaflets, assistance with preparation of educational materials and dissemination of findings. Father and son, Lewis and Archie Veale (now 18years), agreed to be on the Trial Steering Group for this study. They have first-hand experience of the difficulties of ventilator weaning (Archie spent 8 weeks in PICU in 2014). Funding Information: 1Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK 2Northern Ireland Clinical Trials Unit, Belfast, UK 3Centre for Public Health, Institute of Clinical Sciences, Queen's University Belfast, Belfast, UK 4Public Health, Epidemiology and Biostatistics, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK 5Paediatric Intensive Care Unit, Royal Brompton Hospital, London, UK 6Paediatric Intensive Care Unit, Birmingham Women{\textquoteright}s and Children{\textquoteright}s Hospital, Birmingham, UK 7Faculty of Medicine and Health, University of Leeds, Leeds, UK 8Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Trust, London, UK 9Institute of Child Health, University College London, London, UK 10Faculty of Health and Applied Sciences, University of the West of England Bristol, Bristol, UK 11MRC Centre for Inflammation Research, The Queen's Medical Research Institute, The University of Edinburgh, Edinburgh, UK Acknowledgements We thank the following people for their contributions to the set-up and delivery of the SANDWICH trial: Lynn Murphy, NICTU Manager, Pauline Bradley, Data Manager, Gerard O{\textquoteright}Hanlon Data Manager and Ruth Holman, Clinical Trial Administrator; and Dr Katherine Fielding and Professor Gavin Perkins for agreeing to chair the TSC and DMC, respectively. We thank the Paediatric Intensive Care Society—Study Group for their ongoing advice and support of this trial. We also thank the research and clinical staff from the 17 participating sites: 1. Alder Hey Children's Hospital, Liverpool. 2. Royal Belfast Hospital for Sick Children, Belfast. 3. Birmingham Children{\textquoteright}s Hospital, Birmingham. 4. Bristol Royal Children's Hospital, Bristol. 5. Royal Brompton Hospital, London. 6. Addenbrooke's Hospital, Cambridge. 7. Noah's Ark Children's Hospital for Wales, Cardiff. 8. Great Ormond Street Hospital, London. 9. Variety Children's Hospital, King{\textquoteright}s College London. 10. Leeds General Infirmary, Leeds. 11. Royal Victoria Infirmary, Newcastle. 12. John Radcliffe Hospital, Oxford. 13. Southampton General Hospital, Southampton. 14. St George{\textquoteright}s Hospital, London. 15. St Mary{\textquoteright}s Hospital, London. 16. Royal Stoke University Hospital, Stoke-on-Trent.17. Sheffield Children's Hospital, Sheffield. 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{\textquoteright}s University Belfast is the sponsor for the trial. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.",
year = "2019",
month = nov,
day = "1",
doi = "10.1136/bmjopen-2019-031630",
language = "English",
volume = "9",
pages = "e031630",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group Ltd",
number = "11",
}