Status:
RECRUITING
Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
Lead Sponsor:
Zhejiang University
Conditions:
Hypoxemia
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 recen...
Eligibility Criteria
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.
- 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.
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2027
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT07175155
Start Date
October 24 2025
End Date
August 20 2027
Last Update
January 5 2026
Active Locations (4)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
3
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, China, 310000
4
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 310000