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Clinical Trials in China / NCT07051980
Recruiting Phase 2

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

NCT07051980 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase 2
Started
2025-06-12
Last updated
2025-07-17

Condition(s) studied

Choledocholithiasis With Cholecystitis With ObstructionObstructive JaundicePancreatitisCholelithiasis

Investigational drug(s) / intervention(s)

Supraglottic Oxygen Delivery via an Endotracheal Tube

Supraglottic Oxygen Delivery via an Endotracheal Tube: patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years; * The ASA classification ranges from I to III. * Patients have signed the informed consent form. * Patients scheduled to undergo sedated ERCP examination; * The estimated duration of the procedure does not exceed 45 minutes. Exclusion Criteria: * Severe cardiac dysfunction (\<4 METs); * Severe renal insufficiency (requiring preoperative dialysis); * Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy; * Increased intracranial pressure; * Upper respiratory tract infections (oral/nasal/pharyngeal); * Fever (core temperature \>37.5°C); * Confirmed pregnancy or current breastfeeding; * Allergy to sedatives (e.g., propofol) or medical adhesives; * BMI \>30 kg/m²; * Current participation in other clinical trials;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

More Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07051980 on ClinicalTrials.gov ↗ ← All trials in China