ACTRN12615000957594已完成未知
A multicentre, randomised, single-blinded clinical trial comparing the effect of conservative oxygen therapy with standard care on ventilator-free days in mechanically ventilated adults in the intensive care unit.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
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