Tests a combined airway device and high-flow oxygen during sedated endoscopy in obese patients
Tests a breathing device with high-flow oxygen in obese adults having sedated endoscopy.
Plain-language title generated from the registry record
Registry title: Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
Key facts
- Where
- Beijing, Hangzhou, Jinjiang, Lishui, and Taizhou, ChinaSee the 5 sites
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Jinjiang Municipal HospitalJinjiang, ChinaTaking people
- The Fifth Affiliated Hospital of Wenzhou Medical UniversityLishui, ChinaTaking people
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT07175155
- Record updated
- 11 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Known allergy to sedatives (e.g., propofol) or medical adhesives; Other conditions deemed unsuitable by the investigator; Confirmed pregnancy or current breastfeeding; Multiple traumatic injuries; Current participation in another clinical trial.