COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

Zhejiang University

Status and phase: Enrolling; Phase 2

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

Treatments: Device: The COMBO Endoscopy Oropharyngeal Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT07012772

ZJU2025B0632

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

The COMBO Endoscopy Oropharyngeal Airway Group

Experimental group

Description:

In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Treatment:

Device: The COMBO Endoscopy Oropharyngeal Airway