@article{7790431fe78e46f0aef2bec8f99cdb26,
title = "Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial",
abstract = "Background: The effect of conservative vs. liberal oxygen therapy on outcomes of intensive care unit (ICU) patients with hypoxic ischaemic encephalopathy (HIE) is uncertain and will be evaluated in the Low Oxygen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial. Objective: The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial. Design, setting, and participants: LOGICAL is a randomised clinical trial in adults in the ICU who are comatose with suspected HIE (i.e., those who have not obeyed commands following return of spontaneous circulation after a cardiac arrest where there is clinical concern about possible brain damage). The LOGICAL trial will include 1400 participants and is being conducted as a substudy of the Mega Randomised registry trial comparing conservative vs. liberal oxygenation targets in adults receiving unplanned invasive mechanical ventilation in the ICU (Mega-ROX). Main outcome measures: The primary outcome is survival with favourable neurological function at 180 days after randomisation as measured with the Extended Glasgow Outcome Scale (GOS-E). A favourable neurological outcome will be defined as a GOS-E score of lower moderate disability or better (i.e. a GOS-E score of 5–8). Secondary outcomes include survival time, day 180 mortality, duration of invasive mechanical ventilation, ICU length of stay, hospital length of stay, the proportion of patients discharged home, quality of life assessed at day 180 using the EQ-5D-5L, and cognitive function assessed at day 180 using the Montreal Cognitive Assessment (MoCA-blind). Conclusions: The LOGICAL trial will provide reliable data on the impact of conservative vs. liberal oxygen therapy in ICU patients with suspected HIE following resuscitation from a cardiac arrest. Prepublication of the LOGICAL protocol and statistical analysis plan prior to trial conclusion will reduce the potential for outcome-reporting or analysis bias. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).",
keywords = "Cardiac arrest, Hyperoxia, Hypoxia, Hypoxic ischaemic encephalopathy, Oxygen therapy",
author = "Young, {Paul J.} and Hodgson, {Carol L.} and Diane Mackle and Mather, {Anne M.} and Richard Beasley and Rinaldo Bellomo and Stephen Bernard and Kathy Brickell and Deane, {Adam M.} and Glenn Eastwood and Simon Finfer and Higgins, {Alisa M.} and Anna Hunt and Cassie Lawrence and Linke, {Natalie J.} and Edward Litton and McDonald, {Christine F.} and James Moore and Nichol, {Alistair D.} and Shaanti Olatunji and Parke, {Rachael L.} and Sandra Peake and Paul Secombe and Seppelt, {Ian M.} and Anne Turner and Tony Trapani and Andrew Udy and Jessica Kasza and {for the LOGICAL management committee, the Australian and New Zealand Intensive Care Society Clinical Trials Group, and the Irish Critical Care Trials Group}",
note = "Funding Information: The LOGICAL trial is funded by a grant from the National Health and Medical Research Council of Australia, the Irish Critical Care-Clinical Trials Network (HRB–ICC–CTN), and by an unrestricted donation from the Alpha Charitable Trust. The funding bodies have had no input into the design or conduct of the trial or into the statistical analysis plan and will have no input into analysis or reporting of the results. The study is coordinated in New Zealand by the Medical Research Institute of New Zealand and in Australia by the Australian and New Zealand Intensive Care Research Centre. The study is coordinated in Ireland by the Irish Critical Care Clinical Trials Network, which is supported by the Health Research Board. This study is endorsed by the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Irish Critical Care-Clinical Trials Group. Funding Information: The LOGICAL trial is funded by a grant from the National Health and Medical Research Council of Australia, the Irish Critical Care-Clinical Trials Network (HRB–ICC–CTN), and by an unrestricted donation from the Alpha Charitable Trust. The funding bodies have had no input into the design or conduct of the trial or into the statistical analysis plan and will have no input into analysis or reporting of the results. The study is coordinated in New Zealand by the Medical Research Institute of New Zealand and in Australia by the Australian and New Zealand Intensive Care Research Centre. The study is coordinated in Ireland by the Irish Critical Care Clinical Trials Network, which is supported by the Health Research Board . This study is endorsed by the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Irish Critical Care-Clinical Trials Group. Publisher Copyright: {\textcopyright} 2023 The Author(s)",
year = "2023",
month = sep,
doi = "10.1016/j.ccrj.2023.06.007",
language = "English",
volume = "25",
pages = "140--146",
journal = "Critical Care and Resuscitation",
issn = "1441-2772",
publisher = "Elsevier",
number = "3",
}