A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure
研究概览
简要总结
Sedation for endoscopic submucosal dissection 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 submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional 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 sumucosal dissection under remimazolam-based sedation
排除标准
- •dementia or cognitive dysfunction
- •altered mental status
- •intubated patients or tracheostomy
- •pregnancy
- •recent history of nasal bleeding
- •contraindication for positive pressure ventilation
- •patients under oxygen therapy
- •illiteracy or foreigner
研究组 & 干预措施
conventional oxygenation (nasal cannula) arm
conventional oxygenation arm will receive oxygen at 2L/min via nasal cannula
干预措施: conventional oxygenation (nasal cannula) (Device)
high-flow humidified oxygen-delivery system (OptiFlow THRIVE) arm
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) (Device)
结局指标
主要结局
The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure
时间窗: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour
We will record the incidence of hypoxemia during the procedure.
次要结局
- the number and duration of hypoxemia(during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour)
- the end tidal CO2 at the end of the procedure(during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour)
- the lowest SpO2 during procedure(during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour)
- need for airway intervention(during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour)