None listed
Conditions
Brief summary
Adequate delivery of oxygen to the organs is essential for human life and all organs of the body require oxygen to function normally. Normally, oxygen makes up just under a quarter of the gas in the air we breathe. In patients who require life support, much higher amounts of oxygen (up to 100% oxygen) can be used. Sometimes it is necessary to provide higher than normal amounts of oxygen to patients on life support in order to achieve normal levels of oxygen in the blood. However, patients who require life support often receive more oxygen than is absolutely necessary to achieve normal oxygen levels in the blood. This commonly causes abnormally high levels of oxygen in the blood. The purpose of this study is to find out whether a conservative oxygen strategy, which avoids giving more oxygen than is necessary to maintain normal levels of oxygen in the blood, improves ventilator-free days (the number of days free from life support) compared to standard care.
Interventions
The ‘intervention arm’ is a conservative approach to oxygen therapy, which aims to minimise unnecessary exposure to hyperoxaemia and reduce the exposure to higher than necessary inspired oxygen concentrations. When a participant is allocated to conservative oxygen therapy, the inspired oxygen concentration will be decreased to room air as rapidly as possible provided that the SpO2 measured by peripheral pulse oximetry is greater than the acceptable lower limit. SpO2 levels of greater than 96% will be strictly avoided and an upper SpO2 alarm limit of 97% will apply whenever supplemental oxygen is being administered in the ICU to minimise the risk of hyperoxaemia. After extubation, in the conservative oxygen group, the upper monitored alarm limit of acceptable SpO2 of 97% will still 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 lower limit alarm for SpO2 will be set at 90% (or lower if clinically appropriate). If the PaO2 or the SaO2 is lower than the acceptable limit, inspired oxygen may be increased if clinically appropriate, irrespective of the SpO2 reading. The intervention will be applied whenever the patient is in the ICU (including any periods of ICU readmission). The duration of the intervention period is until 28 days or hospital discharge, whichever occurs first. The site principal investigators will take primary responsibility for training local staff and will use study tools provided by the coordinating centre including posters describing the intervention. On-site monitoring will be performed by a project manger from the coordinating centre to ensure compliance with the protocol.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients at least 18 years of age who require invasive mechanical ventilation in the ICU and are expected to be receiving mechanical ventilation beyond the next calendar day.
Exclusion criteria
After enrollment of 100 participants, in response to feedback from site investigators and research coordinators, the exclusion criteria were amended to read as follows: 1. Greater than two hours of invasive mechanical ventilation and/ or non-invasive ventilation in an ICU during this hospital admission (includes time ventilated in another hospital’s ICU) 2. In the view of the treating clinician, hyperoxia is clinically indicated for reasons including (but not limited to) carbon monoxide poisoning or a requirement for hyperbaric oxygen therapy 3. In the view of the treating clinician, avoidance of hyperoxia is clinically indicated for reasons including (but not limited to) chronic obstructive airways disease (COPD), paraquat poisoning, previous exposure to bleomycin, or chronic hypercapnic respiratory failure 4. Pregnancy 5. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient, or the substitute decision maker are not committed to full active treatment 6. Patients with a life expectancy of less than 90 days due to a chronic or underlying medical condition 7. Admitted following a drug overdose (including alcohol intoxication) 8. Long-term dependence on invasive ventilation prior to this acute illness 9. Confirmed or suspected diagnosis of any of the following: Guillain-Barré syndrome, cervical cord injury above C5, muscular dystrophy, or motor neurone disease 10. Enrolment not considered in the patient’s best interests 11. Enrolled in any other trial of targeted oxygen therapy 12. Previously enrolled in the ICU-ROX study