Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation：a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 410
- Locations
- 3
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Investigators
Diansan Su
Chairman of Anesthesiology
Zhejiang University