Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Percentage of participants with ventilator-associated pneumonia
研究概览
简要总结
This is a randomized controlled trial compared two methods to drainage subglottic secretion in prolonged intubated patients.After enrolled, patients are randomized assigned to intermittent subglottic secretion drainage group and air-impingement manipulation group.
详细描述
Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic space is a well-proven cause of VAP. Therefore, prevention should include the aspiration of secretions from the subglottic space. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. This method has been granted as a patent by Chinese national intellectual property patent office, it has been used in investigators' daily work for more than 10 years and more than 20 Chinese ICUs have used it everyday. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Should meet all the criteria:
- •Intubation less than 24 hours before admitting respiratory intensive care unit;
- •Anticipated intubation for more than 72 hours;
- •Anticipated survival time is more than 2 weeks
排除标准
- •Meet any of these criteria:
- •PEEP≥10cmH2O or FiO2≥0.8;
- •unstable hemodynamics;
- •severe bulla and pneumothorax;
- •enrolled in other study;
- •cuff leak test is positive.
结局指标
主要结局
Percentage of participants with ventilator-associated pneumonia
时间窗: Up to 28 days
次要结局
- ICU mortality(Participants will be followed for the duration of ICU stay, an expected average of 4 weeks)
研究者
Jie Li
RRT-NPS
Beijing Chao Yang Hospital