COMBO oropharyngeal airway during sedated ERCP

COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

This test will see if the COMBO Endoscopy Oropharyngeal Airway reduces episodes of low oxygen (hypoxia) in adults undergoing ERCP with propofol sedation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT07012772 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial enrolls adults (ASA I–III) scheduled for ERCP under propofol sedation and uses the COMBO Endoscopy Oropharyngeal Airway, a device combining capnography, a bite block, oxygen delivery, and an oropharyngeal airway, during the procedure. The main outcome is the incidence of hypoxia during procedures expected to last 45 minutes or less. Key exclusions include significant pulmonary disease, severe cardiac or renal dysfunction, coagulopathy, active upper airway infection, pregnancy, and airway anatomy that prevents device use. The study is conducted at the First Affiliated Hospital, Zhejiang University School of Medicine in Hangzhou, China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with ASA physical status I–III who are scheduled for ERCP under propofol sedation for procedures expected to last 45 minutes or less and who can give informed consent.

Not a fit: Patients with COPD or other chronic pulmonary disease requiring oxygen, severe cardiac or renal failure, coagulopathy, active upper respiratory infection, pregnancy, or anatomical issues preventing airway insertion are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could lower the risk of low-oxygen events during sedated ERCP and improve patient safety.

How similar studies have performed: Elements such as capnography monitoring and airway adjuncts have reduced respiratory events during procedural sedation, but the COMBO integrated airway device is relatively new and has limited published trial data.

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.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• he First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital,Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: DiSan Head of Anesthesiology, PhD

Conditions Choledocholithiasis With Cholecystitis With Obstruction; Obstructive Jaundice; Pancreatitis; Cholelithiasis; respiratory depression; The COMBO Endoscopy Oropharyngeal Airway; Hypoxia; Sedation