Actively Recruiting
Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study
Led by Zhejiang University · Updated on 2025-07-17
50
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ASA classification between I and III
- Signed informed consent form
- Scheduled for sedated ERCP examination
- Estimated procedure duration not exceeding 45 minutes
You will not qualify if you...
- Severe cardiac dysfunction (less than 4 METs)
- Severe renal insufficiency requiring preoperative dialysis
- Diagnosed chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases needing ongoing oxygen therapy
- Increased intracranial pressure
- Upper respiratory tract infections (oral, nasal, or pharyngeal)
- Fever with core temperature above 37.5°C
- Confirmed pregnancy or currently breastfeeding
- Allergy to sedatives like propofol or medical adhesives
- Body mass index over 30 kg/m²
- Current participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
D
DiSan Head of Anesthesiology, PhD
CONTACT
L
Lianjuan Sun, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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