High-flow Nasal Cannula Oxygenation in Sedated Endoscopy for High-risk Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy. The STOP-BANG questionnaire is a widely used, simple assessment tool for screening obstructive sleep apnea (OSA) risk. A STOP-Bang score ≥5 indicates high-risk OSA patients who are more prone to hypoxia during sedated endoscopy. Our team's preliminary clinical research found that High-Flow Nasal Cannula (HFNC) may reduce hypoxemia risk, but there are limited dedicated studies focusing specifically on high-risk OSA patients, with controversial results. This study aims to investigate whether HFNC can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in high-risk obstructive sleep apnea patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age ≥18 years.
- •STOP-Bang score ≥
- •Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
- •The estimated duration of the procedure does not exceed 45 minutes.
- •Patients have signed the informed consent form.
排除标准
- •Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions).
- •Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
- •Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
- •Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
- •Confirmed pregnancy or current breastfeeding.
- •Known allergy to sedatives (e.g., propofol) or medical adhesives.
- •Multiple traumatic injuries.
- •Current participation in another clinical trial.
- •Other conditions deemed unsuitable by the investigator.
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 sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
Diansan Su
Chief Physician,Researcher
Zhejiang University