NCT01684124已完成1 期
A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Difference in PaO2/FiO2 ratio from baseline to worst value
研究概览
简要总结
The investigators hypothesize that it is feasible and safe to deliver a conservative approach to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on average,10 days).
详细描述
- Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
- Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
- Target an oxygen saturation between 90 and 92%
- Adjust FiO2 to achieve target SaO2 at all times
- Assess percentage of time patient is within target
- Assess for safety of this approach
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical ventilation
- •expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)
排除标准
- •expected to be off mechanical ventilation today or tomorrow
- •carbon monoxide poisoning
- •necrotizing fasciitis
研究组 & 干预措施
standard care
Placebo Comparator
normal treatment
干预措施: standard care (Other)
conservative O2 therapy
Active Comparator
a value of 90-92% O2 saturation will be targeted
干预措施: conservative O2 therapy (Other)
结局指标
主要结局
Difference in PaO2/FiO2 ratio from baseline to worst value
时间窗: 10 days
Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)
次要结局
- Lactate(10 days)
研究者
Rinaldo Bellomo
Director of ICU Research
Austin Health
研究点 (1)
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