COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

Launched by ZHEJIANG UNIVERSITY · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial, called the COMBO Endoscopy Oropharyngeal Airway study, is looking at a new device designed to help patients breathe better during a specific medical procedure called Endoscopic Retrograde Cholangiopancreatography (ERCP). This procedure is often done to treat conditions related to gallstones and issues with the bile ducts and pancreas. The main goal of the trial is to see if this new device can reduce the risk of low oxygen levels (hypoxia) in patients who are sedated during the procedure, which can be a common problem.

To be eligible for the trial, participants need to be at least 18 years old and scheduled for a sedated ERCP that lasts no longer than 45 minutes. However, certain health conditions, like severe heart or lung problems, recent infections, or being pregnant, could prevent someone from participating. If someone joins the study, they can expect to use the new device during their procedure, and their oxygen levels will be closely monitored. This trial is not currently recruiting participants, but it aims to improve safety for patients undergoing this important medical procedure.

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:
• • 1. Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
• • 2. Severe cardiac dysfunction (\<4 METs);
• • 3. Severe renal insufficiency (requiring preoperative dialysis);
• • 4. Child-Pugh class C;
• • 5. Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
• • 6. Increased intracranial pressure;
• • 7. Upper respiratory tract infections (oral/nasal/pharyngeal);
• • 8. Fever (core temperature \>37.5°C);
• • 9. Confirmed pregnancy or current breastfeeding;
• • 10. Allergy to sedatives (e.g., propofol) or medical adhesives;
• • 11. Emergency procedures;
• • 12. Multiple trauma injuries;
• • 13. Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively;
• • 14. BMI \<18.5 or \>30 kg/m²;
• • 15. Current participation in other clinical trials;
• • 16. Other conditions deemed ineligible by investigators.