RecruitingNot ApplicableNCT07175155

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

Sponsor

Zhejiang University

Enrollment

410 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Gastric Cancer Hypoxemia Morbidly Obese Patients

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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.

Interventions

DEVICECOMBO 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

DEVICEHigh-Flow Nasal Cannula Oxygenation

In this group, patients use high-flow nasal cannula oxygenation