NCT01191489已完成3 期
Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Hospital Infanta Sofia4 个研究点 分布在 1 个国家目标入组 1,042 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,042
- 试验地点
- 4
- 主要终点
- Post-extubation respiratory failure and Reintubation rate
研究概览
简要总结
The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.
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
- Double (Investigator, Outcomes Assessor)
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
- •Low Risk Patients:
- •Any extubated patients after tolerating a spontaneous breathing trial.
- •High Risk Patients:
- •Any extubated patients after >48 hours under mechanical ventilation and any of the following:
- •>65 years
- •cardiac failure as the primary indication of mechanical ventilation
- •APACHE II >12 points the extubation day
- •inability to manage respiratory secretions
- •1 failed spontaneous breathing trial
- •1 comorbidity
- •7 days under mechanical ventilation
排除标准
- •<18 years
- •thacheotomized patients
- •recent facial or cervical trauma/surgery
- •active gastro-intestinal bleeding
- •lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.
结局指标
主要结局
Post-extubation respiratory failure and Reintubation rate
时间窗: 3 months
次要结局
- Intensive Care Unit mortality rate(3 month)
- Hospital mortality rate(6 months)
- Intensive Care Unit length of stay(3 months)
- Hospital length of stay(6 months)
- Nosocomial pneumonia rate(3 months)
- Tracheobronchitis rate(3 months)
研究者
Gonzalo Hernandez Martinez
Gonzalo Hernandez Martinez
Hospital Infanta Sofia
研究点 (4)
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