A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 586
- 试验地点
- 1
- 主要终点
- fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
研究概览
简要总结
We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.
详细描述
The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Age ≥ 18 years old
- •Oral endotracheal intubation and mechanical ventilation > 36 hours
- •Fulfilled the weaning criteria
排除标准
- •The patient has a chest drainage tube and there is persistent air leak
- •Abnormalities of the larynx: such as tumors or vocal cord paralysis
- •The patient cannot maintain the semi-recumbent position
- •Unconventional weaning, such as awake ECMO, etc
- •Participated in the study during the hospitalization
- •Patients or their relatives refused written informed consent
结局指标
主要结局
fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
时间窗: 48 hours
The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
次要结局
- length of hospital(90 days)
- length of ICU(90 days)
- Invasive mechanical ventilation time before first extubation(28 days)
- Post-extubation stridor(24 hours)
- Reintubation within 48 hours after extubation(48 hours)
- required reintubation within 48 hours following extubation(48 hours)
研究者
Bing Sun
professor of treatment
Beijing Chao Yang Hospital