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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-12

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Choledocholithiasis With Cholecystitis With Obstruction Obstructive Jaundice Pancreatitis Cholelithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Supraglottic Oxygen Delivery via an Endotracheal Tube

In this group, patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Group Type EXPERIMENTAL

Supraglottic Oxygen Delivery via an Endotracheal Tube

Intervention Type DEVICE

patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Interventions

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Supraglottic Oxygen Delivery via an Endotracheal Tube

patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No