COMBO oropharyngeal airway during sedated ERCP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: 184872238@qq.com
• Phone: 86+18616514088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.