None listed
Conditions
Brief summary
The purpose of the Mega-ROX study is to determine the effect of two approaches to oxygen therapy on the risk of death in patients who need emergency life support (a breathing machine) in the ICU. Oxygen is essential for life and is given to all patients on life support. Often these patients receive more oxygen than they need to make their body oxygen levels normal. Some research suggests that giving more oxygen than is needed to achieve normal oxygen levels in the body may be harmful while other research suggests that it is not, and it may even be beneficial. This study compares two ways of giving oxygen to patients on life support. The first is to give a little more oxygen and the second is to give a little less. Both approaches are safe but is not clear which approach is the most effective. All patients in this study can be allocated to either of the approaches to oxygen therapy being tested. However, the study is designed so that as the chances that one approach is better for patients with particular problems increases, the number of new patients given oxygen using that approach also increases. In a sense this means that every patient in this study benefits from the information gained from previous patients and every patient helps future patients.
Interventions
Conservative oxygen therapy: the FiO2 will be decreased to 0.21 (room air) as rapidly as possible provided that the SpO2 measured by peripheral pulse oximetry is greater than the acceptable lower limit (the default lower limit will be 90% but this default lower SpO2 alarm can be reduced to a lower level than 90% at the discretion of the treating clinician). SpO2 levels of greater than 94% will be strictly avoided and an upper SpO2 alarm limit of 95% will apply whenever supplemental oxygen is be
Conservative oxygen therapy: the FiO2 will be decreased to 0.21 (room air) as rapidly as possible provided that the SpO2 measured by peripheral pulse oximetry is greater than the acceptable lower limit (the default lower limit will be 90% but this default lower SpO2 alarm can be reduced to a lower level than 90% at the discretion of the treating clinician). SpO2 levels of greater than 94% will be strictly avoided and an upper SpO2 alarm limit of 95% will apply whenever supplemental oxygen is being administered in the ICU to minimise the risk of hyperoxaemia. After extubation, the upper monitored alarm limit of acceptable SpO2 of 95% will apply whenever supplemental oxygen is being administered. In the event that the SpO2 exceeds the acceptable upper limit, downward titration of supplemental oxygen will be undertaken as a high priority and supplemental oxygen will be discontinued as soon possible. The duration of therapy is until discharge from the study ICU, or 90 days from randomisation, whichever is sooner. We will seek to ensure adherence by providing staff with an online study learning package, and through centralised monitoring according to the risk based monitoring plan. This approach will involve reviewing data entered by site staff into the eCRF. Data are reviewed using protocol compliance reporting and direct review of oxygen data entered and assessed according to pre-specified risk indicator thresholds. Specific feedback will be provided to sites with high non-adherence rates and, if necessary such sites will be required to terminate enrolment.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 18 years or older who require invasive mechanical ventilation in the ICU following an emergency (unplanned) ICU admission AND those starting mechanical ventilation in the ICU (i.e. intubated in the ICU) will be eligible for inclusion.
Exclusion criteria
1. Where enrolment is not considered in a particular patient’s best interests by the treating clinician, that patient will be excluded. This exclusion criterion will be modified in jurisdictions where a best interest’s standard does not operate as part of ethics / regulatory requirements. In such jurisdictions this exclusion criterion will be expressed as “the treating clinician considers that one study treatment arm is either indicated or contraindicated. 2. Previously enrolled in Mega-ROX.
Outcome results
None listed