Randomized, Single Blind Study Comparing the Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages in Intensive Care Patients Requiring Prolonged Mechanical Ventilation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Tracheal mucosal damages assessed by tracheal fibroscopy.
研究概览
简要总结
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.
详细描述
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. Tracheal mucosa injuries will be assessed by tracheal fibroscopy. Secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.
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
- •Adult aged 18 years or more
- •Patients hospitalized in intensive care unit
- •Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours
排除标准
- •Pregnant or breast-feeding women
- •Previous known tracheal lesions
- •Persons deprived of freedom
结局指标
主要结局
Tracheal mucosal damages assessed by tracheal fibroscopy.
时间窗: the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)
* stage 0: no lesion * stage 1: erythema * stage 2 : oedema * stage 3 : ulceration * stage 4 : necrosis
次要结局
- Volume of daily secretions(During intubation)
- Occurrence of difficulties or impossibilities of secretion drainage(During intubation)
- Occurrence of ventilator-associated pneumonia(During intubation)