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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of delivering oxygen supraglottically via an endotracheal tube during endoscopic retrograde cholangiopancreatography (ERCP) under deep sedation. ERCP is a procedure used to examine the bile duct, pancreatic duct, and ampulla. Hypoxia is a common cardiopulmonary complication during ERCP, occurring in 16.2 to 39.2% of patients, and proper oxygenation and ventilation are key to preventing it. Participants will receive oxygen delivery through a supraglottic endotracheal tube while undergoing non-intubated ERCP anesthesia. This device-based approach is being studied to see if it reduces hypoxia compared to standard methods like increasing oxygen flow and jaw lifting. The procedure duration is expected to be under 45 minutes. During the hospital stay, which lasts about 2 hours on average, researchers will monitor participants for hypoxia, sub-clinical respiratory depression, and severe hypoxia. Patients will be closely observed throughout the procedure and recovery to assess breathing and oxygen levels. This study is sponsored by Zhejiang University and focuses on patients undergoing sedated ERCP.
CONDITIONS
Brief 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 does not exceed 45 minutes
You will not qualify if you...
- Severe cardiac dysfunction with less than 4 METs capacity
- Severe renal insufficiency requiring preoperative dialysis
- Diagnosed COPD or other pulmonary diseases needing long-term or intermittent oxygen therapy
- Increased intracranial pressure
- Upper respiratory tract infections (oral, nasal, or pharyngeal)
- Fever with core temperature over 37.5°C
- Confirmed pregnancy or current breastfeeding
- Allergy to sedatives such as 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 2 hours
Participants use the supraglottic oxygen delivery device via an endotracheal tube during their sedated ERCP procedure.
1 procedure visit (in-person)
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
L
Lianjuan Sun, Master
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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