NCT00775710已完成4 期
A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
研究概览
简要总结
The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute hypercapnic respiratory failure.
- •Use of NIV to treat respiratory failure.
- •Persistence of hypercapnia after discontinuation of NIV
排除标准
- •Facial or cranial trauma or surgery,
- •Recent gastric or esophageal surgery,
- •Active upper gastrointestinal bleeding,
- •Excessive amount of respiratory secretions,
- •Tracheostomy
- •Lack of cooperation
研究组 & 干预措施
1
Active Comparator
Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure.
干预措施: Nocturnal non-invasive ventilation (Device)
2
No Intervention
Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night.
结局指标
主要结局
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
时间窗: At the end of enrollment time
次要结局
- Incidence of long term dependency on non-invasive ventilation(At the end of enrollment time)
- Hospital and 6-month survival(At the end of enrollment time)
研究者
研究点 (3)
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