Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34132
Title: Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial.
Austin Authors: Young, Paul J;Hodgson, Carol L;Mackle, Diane;Mather, Anne M;Beasley, Richard;Bellomo, Rinaldo ;Bernard, Stephen;Brickell, Kathy;Deane, Adam M;Eastwood, Glenn M ;Finfer, Simon;Higgins, Alisa M;Hunt, Anna;Lawrence, Cassie;Linke, Natalie J;Litton, Edward;McDonald, Christine F ;Moore, James;Nichol, Alistair D;Olatunji, Shaanti;Parke, Rachael L;Peake, Sandra;Secombe, Paul;Seppelt, Ian M;Turner, Anne;Trapani, Tony;Udy, Andrew;Kasza, Jessica
Affiliation: 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, Victoria, Australia.;Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.;Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.;Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.;Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.;Data Analytics Research and Evaluation Centre, Austin Hospital, Melbourne, Victoria, Australia.
Department of Intensive Care & Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.;Department of Intensive Care, Victorian Heart Hospital, Melbourne, Victoria, Australia.
University College Dublin Clinical Research Centre at St Vincents University Hospital, Dublin, Ireland.
Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.;Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Intensive Care
The George Institute for Global Health, University of New South Wales, Sydney, Australia.;Faculty of Medicine, University College London, London, United Kingdom.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Institute for Breathing and Sleep
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
School of Medicine, University of Western Australia, Perth, Western Australia, Australia.;Intensive Care Unit, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, Western Australia, Australia.
Respiratory and Sleep Medicine
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, Victoria, Australia.;Department of Intensive Care & Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.;University College Dublin Clinical Research Centre at St Vincent's University Hospital, Dublin, Ireland.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.;Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.;School of Nursing, The University of Auckland, Auckland, New Zealand.
Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.;Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.
Intensive Care Unit, Alice Springs Hospital, Alice Springs, Northern Territory, Australia.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.;The George Institute for Global Health, University of New South Wales, Sydney, Australia.;Intensive Care Unit, Nepean Hospital, Sydney, New South Wales, Australia.
Medical Research Institute of New Zealand, Wellington, New Zealand.
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Issue Date: Sep-2023
Date: 2023
Publication information: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine 2023-09; 25(3)
Abstract: 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. The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial. 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). 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). 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. Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).
URI: https://ahro.austin.org.au/austinjspui/handle/1/34132
DOI: 10.1016/j.ccrj.2023.06.007
ORCID: 
Journal: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
Start page: 140
End page: 146
PubMed URL: 37876368
Type: Journal Article
Subjects: Cardiac arrest
Hyperoxia
Hypoxia
Hypoxic ischaemic encephalopathy
Oxygen therapy
Appears in Collections:Journal articles

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