NCT03332433已完成不适用
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,034
- 试验地点
- 3
- 主要终点
- Incidence of hypoxia
研究概览
简要总结
Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing gastroscope
- •age over 18 years old
- •Signed informed consent form
排除标准
- •Coagulation disorders or a tendency of nose bleeding;
- •An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- •Severe aortic stenosis or mitral stenosis;
- •Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- •Acute myocardial infarction in the last 6 months;
- •Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability;
- •Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
- •Increased intracranial pressure;
- •ASA >III;
- •Mouth, nose, or throat infection;
- •Fever, defined as core body temperature > 37.5oC ;
- •Pregnancy, breastfeeding or positive pregnancy test
- •Emergency procedure
研究组 & 干预措施
Control group
No Intervention
Oxygen(2L/min) supplied with nasal catheter
High-flow nasal cannula group
Experimental
Oxygen(up to 60L/min) supplied with high-flow nasal cannula
干预措施: High-flow nasal cannula oxygenation (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 of 2 hours
(75% ≤ SpO2 \< 90% for \<60 s)
次要结局
- Other adverse events(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
研究者
diansan su
Vice Chair of the Department of Anesthesiology
RenJi Hospital
研究点 (3)
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