Efficacy and Safety of Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- ventilator weaning days
研究概览
简要总结
The aim of this study is to facilitate weaning by switching between invasive and noninvasive ventilation in difficult-weaning patients.
详细描述
This study only enrolled patients with tracheotomy. When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.A patient in intervention group is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •duration of invasive ventilation ≥14 days
- •anticipation of difficult weaning
- •Glasgow Coma Scale ≥13
- •no upper airway obstruction
- •presence of spontaneous breath
排除标准
- •age less than 18 or more than 85 years
- •contraindications for noninvasive ventilation
- •anticipation of survival less than 6 months
- •refusal of tracheotomy
结局指标
主要结局
ventilator weaning days
时间窗: from enrollment to 90 days
次要结局
- hospital stay days(from admission to 90 days)
- successful weaning rate(from enrollment to 90 days)
- ICU stay days(from admission to 90 days)
- ICU mortality(from admission to 90 days)
- hospital mortality(from admission to 90 days)
研究者
Duan jun
Principal Investigator
Chongqing Medical University