• Paul J Young, Abdulrahman Al-Fares, Diptesh Aryal, Yaseen M Arabi, Muhammad Sheharyar Ashraf, Sean M Bagshaw, Mohd Basri Mat-Nor, Abigail Beane, Giovanni Borghi, Airton L de Oliveira Manoel, Layoni Dullawe, Fathima Fazla, Tomoko Fujii, Rashan Haniffa, Carol L Hodgson, Anna Hunt, Cassie Lawrence, Diane Mackle, Kishore Mangal, Alistair D Nichol, Shaanti Olatunji, Aasiyah Rashan, Sumayyah Rashan, Bruno Tomazini, 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 Irish Critical Care-Clinical Trials Group.
• Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
• Crit Care Resusc. 2023 Mar 1; 25 (1): 535953-59.

BackgroundThe effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults who have nonhypoxic ischaemic encephalopathy acute brain injuries and conditions and are receiving invasive mechanical ventilation in the intensive care unit (ICU) is uncertain.ObjectiveThe objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Brains trial.Design Setting And ParticipantsMega-ROX Brains is an international randomised clinical trial, which 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 between 7500 and 9500 participants with nonhypoxic ischaemic encephalopathy acute brain injuries and conditions who are receiving unplanned invasive mechanical ventilation in the ICU.Main Outcome MeasuresThe primary outcome is in-hospital all-cause mortality up to 90 d 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 Brains will compare the effect of conservative vs. liberal oxygen therapy regimens on 90-day in-hospital mortality in adults in the ICU with acute brain injuries and conditions. The protocol and planned analyses are reported here to mitigate analysis bias.Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).© 2023 The Author(s).

9 keywords...

hide…