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

Daniel S Martin; Tasnin Shahid; Doug W Gould; Alvin Richards-Belle; James C Doidge; Julie Camsooksai; Walton N Charles; Miriam Davey; Amelia Francis Johnson; Roger M Garrett; Michael Pw Grocott; Joanne Jones; Lamprini Lampro; Lorna Miller; B Ronan O'Driscoll; Anthony J Rostron; Zia Sadique; Tamas Szakmany; Paul J Young; Kathryn M Rowan; David A Harrison; Paul R Mouncey

doi:10.1177/17511437241239880

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

J Intensive Care Soc. 2024 Apr 11;25(2):223-230. doi: 10.1177/17511437241239880. eCollection 2024 May.

Authors

Daniel S Martin^{1

2}, Tasnin Shahid³, Doug W Gould³, Alvin Richards-Belle³, James C Doidge³, Julie Camsooksai³, Walton N Charles³, Miriam Davey⁴, Amelia Francis Johnson³, Roger M Garrett⁵, Michael Pw Grocott⁶, Joanne Jones⁴, Lamprini Lampro³, Lorna Miller³, B Ronan O'Driscoll⁷, Anthony J Rostron⁸, Zia Sadique⁹, Tamas Szakmany¹⁰, Paul J Young^{11

12

13

14}, Kathryn M Rowan², David A Harrison², Paul R Mouncey²

Affiliations

¹ Peninsula Medical School, University of Plymouth, Plymouth, UK.
² Intensive Care Unit, University Hospitals Plymouth NHS Trust, Plymouth, UK.
³ Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, London, UK.
⁴ Critical Care, Maidstone and Tunbridge Wells NHS Foundation Trust, Kent, UK.
⁵ Patient and Public Representative, Bristol, UK.
⁶ Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton/University of Southampton, Southampton, UK.
⁷ Respiratory Medicine, Northern Care Alliance NHS Foundation Trust, Salford Royal University Hospital, Salford, UK.
⁸ Integrated Critical Care Unit, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.
⁹ Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.
¹⁰ Critical Care, Aneurin Bevan University Health Board, Cwmbran, UK.
¹¹ Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
¹² Medical Research Institute of New Zealand, Wellington, New Zealand.
¹³ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
¹⁴ Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.

Abstract

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.

Keywords: Oxygen; critical care; hypoxaemia; intensive care; mechanical ventilation.