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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special breathing device (called COMBO endoscopy oropharyngeal airway) combined with high-flow nasal oxygen can safely keep morbidly obese patients breathing well during sedated gastrointestinal (GI) endoscopy procedures. **You may be eligible if...** - You are 18 years or older - You have a BMI of 35 or higher (classified as morbidly obese) - You are scheduled for a gastroscopy or GI endoscopy procedure - The procedure is expected to take 45 minutes or less - You have signed the informed consent form **You may NOT be eligible if...** - You have a bleeding disorder or conditions that make placing the breathing device unsafe - You have an active upper respiratory infection or fever - You have COPD or other serious lung conditions - You have certain conditions that make high-flow oxygen therapy risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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