A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- lowest SpO2 measured with pulse oximetry during the procedure
研究概览
简要总结
Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.
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
- None
盲法说明
Patients will be randomly allocated to 2 groups using computer-generated randomization method. Neither participants nor physicians will be blinded to the groups because of organizational reasons
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation
排除标准
- •dementia or cognitive dysfunction
- •altered mental status
- •intubated patients or tracheostomy
- •recent history of nasal bleeding
- •illiteracy or foreigner
研究组 & 干预措施
standard oxygenation(nasal cannula)
stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula
high-flow humidified oxygen-delivery system(OptiFlow THRIVE)
Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE
干预措施: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) (Biological)
结局指标
主要结局
lowest SpO2 measured with pulse oximetry during the procedure
时间窗: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
The investigators will record the lowest SpO2 during the procedure.
次要结局
- incidence of desaturation below 90% during the procedure(during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography))