COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation: Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients
High-Flow Nasal Cannula Oxygenation: In this group, patients use high-flow nasal cannula oxygenation
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of hypoxemia — Patients will be followed for the duration of hospital stay, an expected average about 2 hours 75% ≤ SpO2 \< 90% for \<60 s
Trial sites (5)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
Jinjiang Municipal Hospital
Jinjiang
Fujian
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
The Fifth Affiliated Hospital of Wenzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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