RecruitingPhase 2NCT07051980

Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study

Sponsor

Zhejiang University

Enrollment

50 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatitis Obstructive Jaundice Cholelithiasis Choledocholithiasis With Cholecystitis With Obstruction

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is a technique for evaluating the bile duct, pancreatic duct, and ampulla. Hypoxia is the most common cardiopulmonary complication during ERCP, with a reported rate of 16.2 to 39.2%. The key to preventing hypoxia is to ensure the sufficient oxygenation and ventilation of patients during these procedures. The commonly used approaches to treat hypoxia with a non-instrumented airway are increasing the oxygen flow and lifting the jaw, applying with both hands, displacing the jaw upwards and anteriorly, which allowed the upper airway to remain open. We hypothesized that the supraglottic oxygen delivery via an endotracheal tube can reduce the incidence of hypoxia in patients under deep sedation during ERCP.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study tests a new method of delivering oxygen during a procedure called ERCP (a procedure to examine and treat problems in the bile ducts or pancreatic duct) without putting a breathing tube down the throat. Researchers use a specially designed endotracheal tube placed above the vocal cords to deliver oxygen while the patient is sedated. **You may be eligible if:** - You are 18 or older - You are in generally good health (ASA classification I–III) - You are scheduled to have a sedated ERCP procedure expected to last no more than 45 minutes - You have signed the informed consent form **You may NOT be eligible if:** - You have severe heart problems or severe kidney disease requiring dialysis - You have COPD or other lung diseases requiring regular oxygen - You have high pressure inside your skull - You have an active infection of the upper respiratory tract (mouth, nose, or throat) - You have a fever - You are pregnant or breastfeeding - You are allergic to sedative drugs (e.g., propofol) or medical adhesives - Your BMI is above 30 - You are currently in another clinical trial 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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