NCT05405530已完成不适用
Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,204
- 试验地点
- 3
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ Age ≤60
- •patients undergoing combined gastroendoscopy and colonoscopy procedure
- •patients signed informed consent form
- •ASA classification I-II
- •Estimated procedure time <=45min
排除标准
- •Coagulation disorders or a tendency of nose bleeding
- •Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
- •Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
- •hypoxia (SpO2< 90 % )
- •Upper respiratory tract infection
- •increased intracranial pressure
- •Fever (core body temperature >37.5 ℃)
- •Pregnancy, breastfeeding, or positive pregnancy test
- •Emergency procedure or surgery
- •Multiple trauma
- •Allergy to propofol or tape and adhesives
- •BMI<18.5 or BMI>30
结局指标
主要结局
The 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% for \<60 s)
次要结局
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of other adverse events(Patients will be followed for the duration of hospital stay, an expected average about 2 hours])
- The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours])
研究者
diansan su
Vice Chair of the Department of Anesthesiology
RenJi Hospital
研究点 (3)
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