Effects of Three Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Microaspiration of Gastric Contents
研究概览
简要总结
The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.
详细描述
In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).
To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.
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
- Single (Participant)
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
- •Volunteering of the patient or relatives who will participate in the study,
- •Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours.
排除标准
- •Patients who are contraindicated in giving a semi-fowler position,
- •Patients with enteral nutrition contraindications,
- •Patients connected to mechanical ventilators for more than 48 hours,
- •Patients with tracheostomy,
- •Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion,
- •Nasal endotracheal intubation.
结局指标
主要结局
Microaspiration of Gastric Contents
时间窗: From randomisation to 48 hours after intubation
The unintentional aspiration of very small amounts of gastric contents
次要结局
未报告次要终点
研究者
Özlem SOYER
Research Assisstant, Msc, RN
Afyonkarahisar Health Sciences University