COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

Phase 2

Recruiting

• Conditions: Choledocholithiasis With Cholecystitis With Obstruction; Obstructive Jaundice; Pancreatitis; Cholelithiasis

• Registration Number: NCT07012772
• Lead Sponsor: Zhejiang University

Brief Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-10
• Study Start: 2025-06-12
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	75% ≤ SpO2 \< 90% for \<60 s

Secondary Outcome Measures

Name	Time	Method
The incidence of sub-clinical respiratory depression	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	90% ≤ SpO2 \< 95%
The incidence of severe hypoxia	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s

Trial Locations

Locations (2)

he First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital,Zhejiang University School of Medicine; 🇨🇳 HangZhou, Zhejiang, China