LOGICAL
Low OxyGen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial
Background: In animal models of cardiac arrest with cardiopulmonary resuscitation, liberal provision of oxygen promotes neuronal damage, worsens cerebral metabolic dysfunction, and increases neurological deficit scores compared to conservative oxygen administration. In the Intensive Care Unit Randomised Oxygen trial (ICU-ROX), among patients with suspected hypoxic ischaemic encephalopathy (HIE) following a cardiac arrest, conservative oxygen therapy was associated with decreased day 180 mortality compared to usual (liberal) oxygen therapy (relative risk 0.73; 95% CI, 0.54 to 0.99; P=0.04). The relative risk of surviving with a favourable neurological outcome at 180 days for conservative vs. liberal oxygen therapy patients was 1.23; 95% CI, 0.95 to 1.59; P=0.13. The aim of the Low OxyGen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial is to test the hypothesis that conservative oxygen therapy increases survival with a favourable neurological outcome at 180 days post randomisation compared to usual (liberal) oxygen therapy.
Design: A total 1,840 patients who are enrolled in Mega Randomised Registry Trial Comparing Liberal vs. Conservative OXygen Targets in Patients with Hypoxic Ischaemic Encephalopathy (Mega-ROX HIE) in Australia and New Zealand will be included in the LOGICAL trial. Allowing for a loss to follow-up of 4%, a sample of 1400 patients will provide 90% power to detect an 8.5% absolute difference between treatment groups in the proportion of patients who survive with a favourable neurological outcome at 180 days based on a control event rate of 32%.
Hypotheses: Among adults with suspected hypoxic ischaemic following a cardiac arrest who are invasively mechanical ventilation in the ICU (participants)
… a conservative oxygen regimen that mandates use of the lowest possible FiO2 to achieve an SpO2 of ≥91% (intervention)
… compared with a liberal oxygen regimen (comparator)
…increases survival with a favourable neurological outcome at 180 days from the date of randomisation (primary outcome)
Funding: NHMRC Clinical Trials and Cohort Studies Grant 2001237
Contact: For further information about this study, please contact Professor Carol Hodgson, or the LOGICAL Project Manager Anne Mather.
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