ArticleCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2023
Protocol and statistical analysis plan for the mega randomised registry trial comparing conservative vs. liberal oxygenation targets in adults with nonhypoxic ischaemic acute brain injuries and conditions in the intensive care unit (Mega-ROX Brains).
Article in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.
- Conservative Oxygen Targets in Mechanically Ventilated Patients (OXY-BREATHES): A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Critical care medicine · 2026Pooled it
- Lower or higher oxygenation targets in the intensive care unit: an individual patient data meta-analysis.Intensive care medicine · 2024Pooled it
- Early Arterial Oxygen Tension Thresholds for Mechanically Ventilated Patients with Non-traumatic Acute Brain Injury: A Bayesian Analysis of Three Large Neurocritical Care Datasets.Neurocritical care · 2026Article
- Beyond one-size-fits-all: Addressing patient heterogeneity through precision-based oxygen therapy research in critical care.Journal of intensive medicine · 2026Article
- Mean arterial pressure targets in intensive care unit patients receiving noradrenaline: An international survey.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025Article
- Protocol and statistical analysis plan for the mega randomised registry trial comparing conservative vs. liberal oxygenation targets in adults in the intensive care unit with suspected hypoxic ischaemic encephalopathy following a cardiac arrest (Mega-ROX HIE).Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2024Article
- Protocol and statistical analysis plan for the identification and treatment of hypoxemic respiratory failure and acute respiratory distress syndrome with protection, paralysis, and proning: A type-1 hybrid stepped-wedge cluster randomised effectiveness-implementation study.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2023Article
- Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 13 institutions in 12 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The 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. Objective: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Brains trial. Design setting and participants: Mega-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 measures: The 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 conclusions: Mega-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 Registration: Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.