Evaluating the effects of two approaches to oxygen therapy in Intensive Care Unit patients requiring life support (mechanical ventilation)
- Conditions
- Critical illnessMechanical ventilationHyperoxaemiaRespiratory failureRespiratory - Other respiratory disorders / diseasesAnaesthesiology - Other anaesthesiology
- Registration Number
- ACTRN12615000957594
- Lead Sponsor
- Medical Research Institute of New Zealand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1000
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method