Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34411
Title: Protocol and statistical analysis plan for the mega randomised registry trial research program comparing conservative versus liberal oxygenation targets in adults receiving unplanned invasive mechanical ventilation in the ICU (Mega-ROX).
Austin Authors: Young, Paul J;Arabi, Yaseen M;Bagshaw, Sean M;Bellomo, Rinaldo ;Fujii, Tomoko;Haniffa, Rashan;Hodgson, Carol L;Vijayaraghavan, Bharath Kumar Tirupakuzhi;Litton, Edward;Mackle, Diane;Nichol, Alistair D;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, VIC, Australia.;Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.
College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.;Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
Department of Critical Care Medicine, University of Alberta and Alberta Health Services, Edmonton, Alberta, Canada.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.;Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.;Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.;Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.;Intensive Care Unit, Jikei University Hospital, Tokyo, Japan.;Department of Health Promotion and Human Behavior, School of Public Health, Kyoto University, Kyoto, Japan.
Nuffield Department of Medicine, University of Oxford, Oxford, UK.;National Intensive Care Surveillance, Mahidol-Oxford Tropical Medicine Research Unit (NICS-MORU), Colombo, Sri Lanka.;University College Hospital, London, UK.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.;Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.;Intensive Care Unit, Alfred Health, Melbourne, VIC, Australia.;George Institute for Global Health, Sydney, NSW, Australia.
Department of Critical Care Medicine, Apollo Hospitals, Chennai, Tamil Nadu, India.;George Institute for Global Health, New Delhi, Delhi, India.
Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, Australia.;Medical School, University of Western Australia, Perth, WA, Australia.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.;Intensive Care Unit, Alfred Health, Melbourne, VIC, Australia.;School of Medicine, University College Dublin, Dublin, Ireland.;Department of Anaesthesia, Intensive Care and Pain Medicine, St Vincent's University Hospital, Dublin, Ireland.
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Intensive Care
Issue Date: 6-Jun-2022
Date: 2023
Publication information: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine 2022-06-06; 24(2)
Abstract: Background: The effect of conservative versus liberal oxygen therapy on 90-day in-hospital mortality in patients who require unplanned invasive mechanical ventilation in an intensive care unit (ICU) is uncertain and will be evaluated in the mega randomised registry trial research program (Mega-ROX). Objective: To summarise the protocol and statistical analysis plan for Mega-ROX. Design, setting and participants: Mega-ROX is a 40 000-patient parallel-group, registry-embedded clinical trial in which adults who require unplanned invasive mechanical ventilation in an ICU will be randomly assigned to conservative or liberal oxygen therapy. Within this overarching trial research program, three nested parallel randomised controlled trials will be conducted. These will include patients with suspected hypoxic ischaemic encephalopathy (HIE) following resuscitation from a cardiac arrest, patients with sepsis, and patients with non-HIE acute brain injuries or conditions. Main outcome measures: The primary outcome is in-hospital allcause mortality up to 90 days from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and proportion of patients discharged home. Results and conclusions: Mega-ROX will compare the effect of conservative versus liberal oxygen therapy on 90-day in-hospital mortality in critically ill adults who receive unplanned invasive mechanical ventilation in an ICU. The protocol and a pre-specified approach to analyses are reported here to mitigate analysis bias. Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTRN 12620000391976).
URI: https://ahro.austin.org.au/austinjspui/handle/1/34411
DOI: 10.51893/2022.2.OA4
ORCID: 
Journal: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
Start page: 137
End page: 149
PubMed URL: 38045600
Type: Journal Article
Appears in Collections:Journal articles

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