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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
DiSan Head of Anesthesiology, PhD
diansansu@yahoo.com
+86 18616514088
Backup
Lianjuan Sun, Master
sunlianjuan26@163.com
+86 18257152767
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Supraglottic Oxygen Delivery via an Endotracheal Tube
In this group, patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov