Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Pepsin level in tracheal aspirate
研究概览
简要总结
We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
详细描述
Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.
In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.
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
- Single (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 > or = 18 years
- •tracheal intubation using a polyvinylchloride tube
- •predictible duration of mechanical ventilation > 48 h
- •enteral nutrition
排除标准
- •refuse to participate to the study
- •no informed consent
- •contra-indication for semirecumbment position
研究组 & 干预措施
Continuous control
Continuous control of cuff pressure using a pneumatic device
干预措施: Continuous control of cuff pressure (Device)
Manual control
Manual control of cuff pressure is a routine practice in ICU patients
干预措施: Manual control of cuff pressure (Device)
结局指标
主要结局
Pepsin level in tracheal aspirate
时间窗: 48 h after randomization
次要结局
- Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions(day 28 after randomization)