MEGA-ROX: Building patient-centric research capacity for better care in oxygen therapy.
The MEGA-ROX Trial
The Mega-ROX trial is a multicentre, multinational, randomized clinical trial to compare conservative oxygen therapy with usual oxygen therapy in mechanically ventilated patients who are either non-electively admitted to the ICU or intubated in the ICU.
MILESTONES
Trial Update: The
Mega-ROX trial has now hit 25,000 enrolments worldwide with only 15,000 more to go.
REPORT
Primary Outcome:
To determine that a conservative approach to oxygen therapy will reduce mortality compared to a liberal approach.
CASE STUDY
“This trial is about so much more than just numbers – it's about redefining what's possible in healthcare and making a lasting impact on patients' lives.”
DIANE MACKLE, PROJECT MANAGER, MEGA-ROX TRIAL
Background
Provision of life support (mechanical ventilation) is required for most critically ill patients who are admitted to an intensive care unit (ICU). Delivery of supplemental oxygen to ICU patients who require mechanical ventilation often exposes them to a high fraction of inspired oxygen (FIO2) and higher than normal arterial oxygen partial pressure (PaO2).
Patients with acute hypoxemic respiratory failure in the intensive care unit (ICU) are treated with supplemental oxygen, but the benefits and harms of different oxygenation targets are unclear. It was hypothesized that using a lower target for partial pressure of arterial oxygen (Pao2) would result in lower mortality than using a higher target.
The ICU-ROX trial findings did not exclude clinically important effects of the oxygen regimens tested on mortality.
Trial design
Mega-ROX is a series of multicentre, multinational, randomised, parallel-group, registry-embedded clinical trials nested within an overall 40,000-patient trial sample.
This 40,000 participant trial will be conducted in multiple countries and includes innovative trial design features:
Linkage to identify enrolled patients in national ICU registries so that outcome data do not need to be collected specifically for the trial;
Response adaptive randomisation giving trial participants an increased chance of being assigned to the oxygen regimen associated with the lowest mortality risk while the trial is ongoing (based on accumulated data within individual subgroups).
Due to updates in Spiral’s Spinnaker platform, Mega-ROX has been translated into Portuguese, allowing for the first Brazilian patient to be enrolled in 2022.
Key connections
Principal Investigator, Paul Young. Deputy Director, Intensive Care Specialist, Medical Research Institute of New Zealand.
Trial Manager, Diane Mackle. ICU Principal, Medical Research Institute of New Zealand.
EDC Platform Project Manager, Emma Winks. Project Manager, Spiral.
“It is easy to get caught up in the emotions of this role but at the same time, it is incredibly rewarding.”
Spiral’s contribution
Our Spiral Project Lead and EDC Platform manager for the MEGA -ROX study is Emma Winks
As a Project Manager at Spiral, Emma oversees software development used in clinical trials. She is used to working with lots of moving parts with a laser-beam focus.