Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation

June 9, 2026 updated by: Diansan Su, Zhejiang University

Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation：a Randomized Controlled Trial

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300100
        • Tianjin Nankai Hospital, Tianjin Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
        • Contact:
      • Hangzhou, Zhejiang, China, 310011
        • Shulan (Hangzhou) Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age≥18years
  • The ASA classification ranges from I to III
  • Patients have signed the informed consent form
  • Patients scheduled to undergo sedated ERCP examination procedure

Exclusion Criteria:

  • Severe cardiac dysfunction (<4 METs);
  • Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
  • Upper respiratory tract infections including oral, nasal or pharyngeal infections;
  • Fever (core temperature >37.5°C);
  • Confirmed pregnancy or current breastfeeding;
  • Hypersensitivity to sedative drugs such as propofol;
  • Current participation in other clinical trials;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
In this group, patients received supraglottic oxygenation via an oral transtracheal catheter
Device: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
Patients received supraglottic oxygenation via an oral transtracheal catheter
Active Comparator: The Regular Nasal Cannula Group
In this group, patients received oxygenation via the regular nasal cannula
Device: The Regular Nasal Cannula
Patients received oxygenation via the regular nasal cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypoxia
Time Frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
75%≤SpO2<90%for<60s
Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of sub-clinical respiratory depression
Time Frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
SpO2<75%or75%≤SpO2<90%for ≥60s
Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
The incidence of severe hypoxia
Time Frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
SpO2<75%or75%≤SpO2< 90%for≥60s
Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 12, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2025C221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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