COMBO airway plus high-flow nasal oxygen during sedated gastrointestinal endoscopy for morbidly obese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Morbid obesity (BMI ≥35) carries a high risk of hypoxemia during sedated gastrointestinal endoscopy, often exceeding 40%. The COMBO Endoscopy Oropharyngeal Airway is a multifunctional device that provides an oropharyngeal airway, bite block, capnography monitoring, and oxygen delivery; this trial pairs it with high-flow nasal cannula (HFNC) oxygen. Participants undergoing gastroscopy or endoscopy lasting ≤45 minutes will receive either the COMBO device plus HFNC or HFNC alone while oxygenation and capnography are monitored. The main outcome is the incidence of hypoxemia, with additional safety and feasibility measures recorded.

Why it matters

Who can join: the full rules

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's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Jinjiang Municipal Hospital
  Jinjiang, Fujian, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The Fifth Affiliated Hospital of Wenzhou Medical University
  Lishui, Zhejiang, China Recruiting
• Taizhou Hospital of Zhejiang Province
  Taizhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Diansan Su, Chief Physician
• Email: diansansu@yahoo.com
• Phone: +8618616514088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.