Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
Recruiting · NCT07175155 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhejiang University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
5 locations listed.
- Peking University First Hospital - Beijing, Beijing Municipality, China
- Jinjiang Municipal Hospital - Jinjiang, Fujian, China
- The First Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- The Fifth Affiliated Hospital of Wenzhou Medical University - Lishui, Zhejiang, China
- Taizhou Hospital of Zhejiang Province - Taizhou, Zhejiang, China