NCT07175155Recruiting
Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 9 Sept 2025
- Start date
- 24 Oct 2025
- Primary completion date
- 20 Aug 2027
- Lead sponsor
- Zhejiang University
- Diseases
- Obesity, Gastric and esophageal cancer
- NCT number
- NCT07175155
What you commit to
- Study type: Interventional
- Planned participants: 410
- From 24 Oct 2025 to the primary completion date, 20 Aug 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Confirmed pregnancy or current breastfeeding.
- Multiple traumatic injuries.
- Current participation in another clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Jinjiang Municipal Hospital Coordinator of this site? Confirm its status | Jinjiang | China | Recruiting |
| The Fifth Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.