Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 15
- 主要终点
- Microaspiration of gastric contents
研究概览
简要总结
The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
详细描述
Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.
Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.
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
- •predictable duration of mechanical ventilation > 48h
- •enteral nutrition
排除标准
- •pregnant women
- •refuse to participate to the study
- •no informed consent
- •contre indication for semirecumbent position
研究组 & 干预措施
tapered PVC-cuffed tracheal tubes
Patients in this arm will be intubated with tapered PVC-tracheal tubes
干预措施: tapered PVC-cuffed tracheal tubes (Device)
Standard PVC-cuffed tracheal tube
Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes
干预措施: Standard PVC-cuffed tracheal tube (Device)
结局指标
主要结局
Microaspiration of gastric contents
时间窗: 48 hours after randomization
Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents
次要结局
- Microaspiration of oropharyngeal secretions(48 h after randomization)
- Tracheobronchial colonization(28 days after randomization)
- Ventilator-associated pneumonia(28 days after randomization)