Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients : A Multicentre Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Incidence of hypoxia
研究概览
简要总结
High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 < 90% and < 60S), severe hypoxia (SpO2<75% for any duration or 75%≤SpO2 < 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 < 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ age ≤80, gender is not limited;
- •Patients undergoing elective gastroenteroscopy or treatment;
- •ASA grade Ⅲ~Ⅳ;
- •18 kg/m2≤BMI≤28kg/m2;
- •The operation time of gastroenteroscopy is expected to be no more than 60min;
- •Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members.
排除标准
- •Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
- •acute respiratory infections and asthma attacks;
- •Patients diagnosed with COPD;
- •Clear difficult airway;
- •Acute upper gastrointestinal bleeding with shock;
- •Gastrointestinal obstruction with gastric content retention;
- •Allergic to sedatives such as propofol;
- •Persons with no capacity for civil conduct such as cognitive dysfunction.
研究组 & 干预措施
High-flow nasal catheter oxygen
干预措施: High-flow nasal catheter oxygen (Device)
Regular nasal catheter oxygen
干预措施: regular nasal catheter oxygen (Device)
结局指标
主要结局
Incidence of hypoxia
时间窗: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75%≤ SpO2 \< 90% and \< 60S
次要结局
- Incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- Incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
Diansan Su
Chief, Department of Anesthesiology, the First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang University