Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical...

Area of Science:

• Critical Care Medicine
• Cardiovascular Research
• Respiratory Physiology

Background:

• Patients on venoarterial extracorporeal membrane oxygenation (VA ECMO) face risks of arterial hyperoxia and hypoxia.
• Optimizing oxygen saturation is crucial to improve outcomes in critically ill patients.

Purpose of the Study:

• To describe the protocol and statistical analysis plan for the Blend to Limit OxygEN in ECMO (BLENDER) Trial.
• To compare conservative versus liberal oxygenation strategies in VA ECMO patients.

Main Methods:

• A pragmatic, multicentre, registry-embedded, randomised clinical trial.
• Enrolling patients on VA ECMO for cardiogenic shock or cardiac arrest in the Australian national ECMO registry.
• Comparing a conservative (92-96% SpO2) with a liberal (97-100% SpO2) oxygenation strategy.

Main Results:

• Primary outcome: intensive care unit (ICU)-free days at day 60.
• Secondary outcomes: duration of mechanical ventilation, mortality, hypoxic episodes, neurocognitive outcomes, and health economics.
• Sample size of 300 patients to detect a 3-day difference in ICU-free days.

Conclusions:

• The BLENDER trial protocol and statistical analysis plan are detailed.
• This study will provide critical data on oxygenation strategies in VA ECMO.
• Findings will guide clinical practice for managing oxygenation in critically ill patients.