NCT03121482已完成不适用
High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Reintubation at Day 7
研究概览
简要总结
Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of mechanical ventilation prior to extubation at least 24h
- •Planned extubation decided by the physician in charge of the patient after success of a weaning trial
- •Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
排除标准
- •Patient admitted for traumatic brain injury
- •Periphal neuromuscular disease as reason for intubation
- •Usual lon-term treatment with NIV for chronic desease
- •Usual lon-term treatment with CPAP for obstructive apneas syndrome
- •Contraindication to NIV
- •Unplanned extubation
- •Do-not-reintubated order at time of extubation
- •Terminal extubation for end of life
- •People under legal protection
- •Opposition to participate
研究组 & 干预措施
HFNC and NIV
Experimental
干预措施: HFNC (Device)
HFNC and NIV
Experimental
干预措施: NIV (Device)
HFNC alone
Active Comparator
Control group
干预措施: HFNC (Device)
结局指标
主要结局
Reintubation at Day 7
时间窗: up to 7 days
The rate of reintubation will be assessed within the 7 days following planned extubation
次要结局
未报告次要终点
研究者
研究点 (2)
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