Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.
详细描述
The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. 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. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.
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
- fatal complications(from sedation initiation to 20 min after patients are awake)
- respiratory-related complications(During sedation procedure)
- cardiovascular-related complications(During sedation procedure)
研究者
Yi Feng, MD
Chair of Department of Anesthesiology
Peking University People's Hospital