None listed
Conditions
Brief summary
This randomised controlled trial will compare the effect of liberal vs. conservative oxygen therapy on survival and neurological function at six months in adults who are comatose following resuscitation from a cardiac arrest. The study hypothesis is that conservative use of oxygen (giving the smallest amount of oxygen possible to achieve safe oxygen levels in the blood) will increase the number of patients who survive with good neurological function.
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 bei
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. Conservative oxygen therapy will be initiated immediately post randomisation (with randomisation required within 12 hours of unplanned invasive mechanical ventilation in an ICU). The duration of conservative oxygen 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 directly monitoring adherence in all participants via the study website. Participant oxygen levels will be reviewed by the project management team after they have been uploaded to the study website. 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
1. Aged greater than or equal to 18 years AND 2. Receiving invasive mechanical ventilation in the ICU following a cardiac arrest AND 3. Suspected of having hypoxic ischaemic encephalopathy (i.e. the patient has not obeyed commands following resuscitation from a cardiac arrest and there is clinical concern about possible brain damage)
Exclusion criteria
1. Enrolment is not considered in the patient’s best interests by the treating clinician (e.g. the patient is expected to die and is not being treated with curative intent or the treating clinician considers that one study treatment arm is either indicated or contraindicated) OR 2. Previously enrolled in the Mega-ROX trial OR 3. Greater than 12 hours have elapsed since the patient fulfilled the inclusion criteria When a patient is not enrolled within 12 hours of fulfilling the eligibility criteria, he /she will be counted as “eligible but missed” rather than “excluded” for the purposes of describing participant flow.
Outcome results
None listed