Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 1
- 主要终点
- Microaspiration as Measured by Tracheal Amylase
研究概览
简要总结
Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is often associated with complications, such as infection and lung injury. Leakage of secretions around the breathing tube (microaspiration) is a major factor leading to complications. The investigators propose that a standardized, enhanced oral suction protocol will be effective in reducing microaspiration and harms associated with mechanical ventilation. The investigators hypothesize that those randomized to the enhanced oral suction protocol will have less microaspiration and other ventilator-associated conditions than those in the usual care, standard suction group.
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, Care Provider, 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
- •18 years of age or older
- •orally intubated with endotracheal tube and treated with mechanical ventilation
- •24 hours or less since intubation
- •expected to be intubated for at least 36 hours after enrollment
排除标准
- •documented aspiration at time of intubation
- •intubation to treat known aspiration
- •treatment with rescue mechanical ventilation therapies (oscillator)
- •re-intubation
- •contraindications to receiving the intervention (e.g., oral injuries)
- •history of lung or head/neck cancers that may produce amylase in the lungs
- •history of disease that affects saliva production (e.g., Sjögren's syndrome)
- •prisoners
研究组 & 干预措施
Enhanced oral suction
Deep oropharyngeal suction with catheter
干预措施: Enhanced oropharyngeal suction (Other)
Usual Care Oral Suction
Oropharyngeal suction with suction swab
干预措施: Usual Care (Other)
结局指标
主要结局
Microaspiration as Measured by Tracheal Amylase
时间窗: Every 12 hours up to 14 days
Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.
Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant
时间窗: Every 12 hours up to 14 days
Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria
次要结局
- Time to VAC(VAC was assessed for two days beyond the last intervention; mean 5.4 days)
- Ventilator-Associated Condition (VAC) Rate(VAC assessed for 2 days beyond last intervention; mean 5.4 days)