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).

  • The ICU-ROX trial findings did not exclude clinically important effects of the oxygen regimens tested on mortality.


  • 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.

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:

    1. Linkage to identify enrolled patients in national ICU registries so that outcome data do not need to be collected specifically for the trial;

    2. 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

“My systematic thinking approach is focused on delivering platform solutions that improve process efficiencies for Spiral's clients and contribute to their trial's success.”

Spiral’s contribution

Our Spiral Project Lead and EDC Platform manager for the MEGA -ROX study is Gosia Costar

Gosia Costar is one of our dedicated Project Managers here at Spiral. Her passion for enhancing health outcomes through innovative technology makes her the perfect addition to our team.