RecruitingNot ApplicableNCT06796764

COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial


Sponsor

Zhejiang University

Enrollment

580 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a special mouthpiece (oropharyngeal airway device) inserted during sedated endoscopy (camera examination of the stomach and colon) in overweight patients to see if it reduces episodes of low oxygen levels. Obese patients are at higher risk for breathing problems during sedation, and this device aims to keep the airway open. **You may be eligible if...** - You are between 18 and 70 years old - Your BMI is 28 or higher (overweight to obese range) - You are scheduled to have both a gastroscopy (stomach camera) and colonoscopy under sedation - You are in generally good health (ASA classification I or II) - The procedure is expected to take 45 minutes or less **You may NOT be eligible if...** - You have a bleeding disorder or are prone to mouth/nose bleeding - You have severe heart, kidney, or liver problems - You have chronic obstructive pulmonary disease (COPD) or other significant respiratory conditions - You have anatomical features in your mouth or throat that prevent device placement 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

DEVICEthe COMBO Endoscopy Oropharyngeal Airway Group

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

DEVICERegular Nasal Cannula

Using regular nasal cannula for oxygenation.


Locations(3)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer hospital

Hangzhou, Zhejiang, China

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NCT06796764


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