• Paul J Young, Abdulrahman Al-Fares, Diptesh Aryal, Yaseen M Arabi, Muhammad Sheharyar Ashraf, Sean M Bagshaw, Abigail Beane, Airton L de Oliveira Manoel, Layoni Dullawe, Fathima Fazla, Tomoko Fujii, Rashan Haniffa, Mohd Shahnaz Hasan, Carol L Hodgson, Anna Hunt, Cassie Lawrence, Israel Silva Maia, Diane Mackle, Giacomo Monti, Alistair D Nichol, Shaanti Olatunji, Sristi Patodia, Aasiyah Rashan, Sumayyah Rashan, Jessica Kasza, Mega-ROX management committee, Australian and New Zealand Intensive Care Society Clinical Trials Group, Brazilian Research in Intensive Care Network, Critical Care Asia and Africa Network, and, and Irish Critical Care-Clinical Trials Group.
• Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
• Crit Care Resusc. 2024 Jun 1; 26 (2): 879487-94.

BackgroundThe effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with hypoxic ischaemic encephalopathy (HIE) following a cardiac arrest who are receiving invasive mechanical ventilation in the intensive care unit (ICU) is uncertain.ObjectiveTo summarise the protocol and statistical analysis plan for the Mega-ROX HIE trial.Design Setting And ParticipantsMega-ROX HIE is an international randomised clinical trial that will be conducted within an overarching 40,000-participant registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We expect to enrol approximately 4000 participants with suspected HIE following a cardiac arrest who are receiving invasive mechanical ventilation in the ICU.Main Outcome MeasuresThe primary outcome is in-hospital all-cause 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 the proportion of participants discharged home.Results And ConclusionsMega-ROX HIE will compare the effect of conservative vs. liberal oxygen therapy regimens on day-90 in-hospital mortality in adults in the ICU with suspected HIE following a cardiac arrest. The protocol and planned analyses are reported here to mitigate analysis bias.Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).© 2024 College of Intensive Care Medicine of Australia and New Zealand. Published by Elsevier B.V.

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