Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care: Protocol for the UK-ROX trial.

Autor:	Martin DS; Peninsula Medical School, University of Plymouth, Plymouth, UK.; Intensive Care Unit, University Hospitals Plymouth NHS Trust, Plymouth, UK., Shahid T; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Gould DW; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Richards-Belle A; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Doidge JC; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Camsooksai J; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Charles WN; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Davey M; Critical Care, Maidstone and Tunbridge Wells NHS Foundation Trust, Kent, UK., Francis Johnson A; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Garrett RM; Patient and Public Representative, Bristol, UK., Grocott MP; Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton/University of Southampton, Southampton, UK., Jones J; Critical Care, Maidstone and Tunbridge Wells NHS Foundation Trust, Kent, UK., Lampro L; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., Miller L; Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK., O'Driscoll BR; Respiratory Medicine, Northern Care Alliance NHS Foundation Trust, Salford Royal University Hospital, Salford, UK., Rostron AJ; Integrated Critical Care Unit, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK., Sadique Z; Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK., Szakmany T; Critical Care, Aneurin Bevan University Health Board, Cwmbran, UK., Young PJ; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.; Medical Research Institute of New Zealand, Wellington, New Zealand.; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.; Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia., Rowan KM; Intensive Care Unit, University Hospitals Plymouth NHS Trust, Plymouth, UK., Harrison DA; Intensive Care Unit, University Hospitals Plymouth NHS Trust, Plymouth, UK., Mouncey PR; Intensive Care Unit, University Hospitals Plymouth NHS Trust, Plymouth, UK.
Jazyk:	angličtina
Zdroj:	Journal of the Intensive Care Society [J Intensive Care Soc] 2024 Apr 11; Vol. 25 (2), pp. 223-230. Date of Electronic Publication: 2024 Apr 11 (Print Publication: 2024).
DOI:	10.1177/17511437241239880
Abstrakt:	Background: In the United Kingdom, around 184,000 adults are admitted to an intensive care unit (ICU) each year with over 30% receiving mechanical ventilation. Oxygen is the commonest therapeutic intervention provided to these patients but it is unclear how much oxygen should be administered for the best clinical outcomes. Methods: The UK-ROX trial will evaluate the clinical and cost-effectiveness of conservative oxygen therapy (the minimum oxygen concentration required to maintain an oxygen saturation of 90% ± 2%) versus usual oxygen therapy in critically ill adults receiving supplemental oxygen when invasively mechanically ventilated in ICUs in England, Wales and Northern Ireland. The trial will recruit 16,500 patients from approximately 100 UK adult ICUs. Using a deferred consent model, enrolled participants will be randomly allocated (1:1) to conservative or usual oxygen therapy until ICU discharge or 90 days after randomisation. Objectives: The primary clinical outcome is all cause mortality at 90 days following randomisation. Discussion: The UK-ROX trial has received ethical approval from the South Central - Oxford C Research Ethics Committee (Reference: 20/SC/0423) and the Confidentiality Advisory Group (Reference: 22/CAG/0154). The trial commenced in May 2021 and, at the time of publication, 95 sites had opened to recruitment. Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. (© The Intensive Care Society 2024.)
Databáze:	MEDLINE
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