RecruitingPhase 2NCT07012772

COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients


Sponsor

Zhejiang University

Enrollment

50 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. 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 of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specially designed airway device (called a COMBO endoscopy oropharyngeal airway) to help maintain safe breathing during ERCP — a procedure that uses a camera to examine and treat problems in the bile ducts and pancreas — when patients are sedated. **You may be eligible if...** - You are 18 or older - You are scheduled for a sedated ERCP procedure expected to take less than 45 minutes - Your overall health risk is classified as ASA I to III (meaning you are reasonably healthy or have mild-to-moderate medical conditions) - You have signed informed consent **You may NOT be eligible if...** - You have a bleeding disorder, oral/nasal bleeding tendency, or lesions in your airway - You have severe heart disease, significant lung disease, or morbid obesity - Your airway is assessed as difficult to manage - You are pregnant 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

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.


Locations(2)

he First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07012772


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