High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease: A Single-Arm Simon Two-Stage Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The incidence of hypoxemia
研究概览
简要总结
Hypoxemia is the most common adverse event during propofol sedation for gastrointestinal endoscopy in patients with chronic obstructive pulmonary disease (COPD) due to diminished pulmonary reserve. Although high-flow nasal cannula (HFNC) oxygenation has been shown to effectively reduce hypoxemia during sedated endoscopy in obese patients, its application in COPD patients remains an evidence gap, largely owing to the traditional concern that high-concentration oxygen may suppress respiratory drive and exacerbate CO₂ retention. This study aims to investigate whether HFNC can reduce the incidence of hypoxemia during sedated gastrointestinal endoscopy in patients with COPD.
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;
- •Confirmed diagnosis of chronic obstructive pulmonary disease (COPD);
- •Scheduled for elective sedated gastroenteroscopy (gastroscopy, colonoscopy, or combined gastroscopy and colonoscopy);
- •Expected procedure duration ≤45 minutes;
- •Provision of written informed consent by the participant.
排除标准
- •Patients with absolute contraindications to high-flow therapy, including but not limited to confirmed diagnosis of complete upper airway obstruction, basilar skull fracture or nasal bone fracture, pneumothorax, or pneumomediastinum.;
- •American Society of Anesthesiologists (ASA) Physical Status class ≥ IV;
- •Requirement for planned endotracheal intubation;
- •Existing tracheostomy;
- •Confirmed pregnancy or currently breastfeeding;
- •Known allergy to sedative agents such as propofol;
- •Current participation in another interventional clinical trial;
- •Any other condition deemed by the investigator to make the patient unsuitable for trial participation.
研究组 & 干预措施
High-flow nasal cannula
Using high-flow nasal cannula oxygenation
干预措施: High-flow nasal cannula (Device)
结局指标
主要结局
The incidence of hypoxemia
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 hypoxemia(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)
研究者
Diansan Su
Chief Physician,Researcher
Zhejiang University