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

NCT07051980 | Recruiting Phase 2

• 1 other identifier: ZJU2025B0679
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Choledocholithiasis With Cholecystitis With Obstruction; Obstructive Jaundice; Pancreatitis; Cholelithiasis

Keywords

ERCP; respiratory depression; Hypoxia; Sedation

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  75% ≤ SpO2 \< 90% for \<60 s

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcomes (2)

• The incidence of sub-clinical respiratory depression

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• The incidence of severe hypoxia

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcomes (1)

• The incidence of other adverse events

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study Arms (1)

Supraglottic Oxygen Delivery via an Endotracheal Tube

EXPERIMENTAL

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

Device: Supraglottic Oxygen Delivery via an Endotracheal Tube

Interventions

Supraglottic Oxygen Delivery via an Endotracheal Tube DEVICE

patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Supraglottic Oxygen Delivery via an Endotracheal Tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Jaundice, Obstructive; Pancreatitis; Cholelithiasis; Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Biliary Tract Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Central Study Contacts

DiSan Head of Anesthesiology, PhD

CONTACT

+86 18616514088; diansansu@yahoo.com

Lianjuan Sun, Master

CONTACT

+86 18257152767; sunlianjuan26@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-06

Locations

CN (1)