Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 410
- 试验地点
- 5
- 主要终点
- The incidence of hypoxemia
研究概览
简要总结
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
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
- •Age ≥ 18 years.
- •BMI ≥ 35 kg/m².
- •Patients undergoing gastroscopy or gastrointestinal endoscopy.
- •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, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.
- •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.
研究组 & 干预措施
COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
干预措施: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation (Device)
High-Flow Nasal Cannula Oxygenation
In this group, patients use the High-Flow Nasal Cannula Oxygenation
干预措施: High-Flow Nasal Cannula Oxygenation (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 hypoxaemia(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