Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study
Launched by ZHEJIANG UNIVERSITY · Jun 26, 2025
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new way to deliver oxygen to patients undergoing a procedure called ERCP, which looks at the tubes that carry bile and pancreatic juices in the body. During this procedure, patients are often deeply sedated but still breathing on their own. A common problem is low oxygen levels (called hypoxia), which can be risky. This study is exploring whether giving oxygen through a special tube placed just above the voice box can help reduce the chances of low oxygen during the procedure.
Adults aged 18 and older who are generally healthy or have mild to moderate health issues (as determined by a standard health classification) and who are scheduled for a sedated ERCP lasting no more than 45 minutes may be eligible. People with serious heart or lung problems, infections, high fever, pregnancy, or allergies to certain sedatives would not qualify. Participants can expect to receive oxygen through this new method while under sedation during their ERCP, with careful monitoring to see if it helps keep oxygen levels stable and makes the procedure safer. This study is not yet recruiting but aims to find a better way to protect patients’ breathing during ERCP.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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;
About Zhejiang University
Zhejiang University is a prestigious research institution located in Hangzhou, China, renowned for its commitment to advancing medical science and healthcare innovation. With a strong emphasis on interdisciplinary collaboration and cutting-edge research, the university plays a pivotal role in the development and execution of clinical trials aimed at improving patient outcomes and enhancing therapeutic approaches. Leveraging its extensive resources and expertise, Zhejiang University is dedicated to fostering advancements in medical knowledge while ensuring the highest standards of ethical conduct and scientific rigor in all its clinical research endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hangzhou, Zhejiang, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported