Supraglottic Jet Oxygenation and Ventilation (SJOV) for Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High-altitude
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Hypoxia during sedation
研究概览
简要总结
This study aims to determine whether the use of SOJV could reduce the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients sedated at high altitude comparing to the supplemental oxygen administration via nasal cannula.
详细描述
The participants will be randomly allocated to either SJOV or nasal cannula oxygen supply in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the nasal cannula oxygen supply group, oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port.
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
- 是
入选标准
- •18 years or older;
- •underwent routine gastrointestinal endoscopy under procedural sedation;
- •consented to participate in this trial. -
排除标准
- •infection of the upper airway;
- •anatomical abnormalities of the face, nose, and upper airway;
- •coagulopathies;
- •anticipated or known difficult airway;
- •known allergy against propofol, soybeans, and egg;
- •absence from the high-altitude environment during the past 3 months. -
结局指标
主要结局
Hypoxia during sedation
时间窗: During sedation procedure
An SPO2 of 75 - 89% for \< 60 s
次要结局
- respiratory-related complications(During sedation procedure)
- cardiovascular-related complications(During sedation procedure)
- fatal complications(from sedation initiation to 20 min after patients are awake)
研究者
Yi Feng, MD
Chair of Department of Anesthesiology
Peking University People's Hospital