• NielsenFrederik MølgaardFM0000-0002-0071-1203Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.Collaboration for Research in Intensive Care (CR, Thomas Lass Klitgaard, Niels Henrik Bruun, MøllerMorten HylanderMH0000-0002-6378-9673Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark., Olav Lilleholt Schjørring, and Bodil Steen Rasmussen.
• Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
• Acta Anaesthesiol Scand. 2023 Jul 1; 67 (6): 811819811-819.

BackgroundSupplemental oxygen therapy is central to the treatment of acute hypoxaemic respiratory failure, a condition which remains a major driver for morbidity and mortality in intensive care. Despite several large randomised clinical trials comparing a higher versus a lower oxygenation target for these patients, significant differences in study design impede analysis of aggregate data and final clinical recommendations.MethodsThis paper presents the protocol for conducting an individual patient data meta-analysis where full individual patient data according to the intention-to-treat principle will be pooled from the HOT-ICU and HOT-COVID trials in a one-step procedure. The two trials are near-identical in design. We plan to use a hierarchical general linear mixed model that accounts for data clustering at a trial and site level. The primary outcome will be 90-day all-cause mortality while the secondary outcome will be days alive without life-support at 90 days. Further, we outline 14 clinically relevant predefined subgroups which we will analyse for heterogeneity in the intervention effects and interactions, and we present a plan for assessing the credibility of the subgroup analyses.ConclusionThe presented individual patient data meta-analysis will synthesise individual level patient data from two of the largest randomised clinical trials on targeted oxygen therapy in intensive care. The results will provide a re-analysis of the intervention effects on the pooled intention-to-treat populations and facilitate subgroup analyses with an increased power to detect clinically important effect modifications.© 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

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