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Clinical Trials in China / NCT07012772
Recruiting Phase 2

COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

NCT07012772 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase 2
Started
2025-06-12
Last updated
2025-06-24

Condition(s) studied

Choledocholithiasis With Cholecystitis With ObstructionObstructive JaundicePancreatitisCholelithiasis

Investigational drug(s) / intervention(s)

The COMBO Endoscopy Oropharyngeal Airway

The COMBO Endoscopy Oropharyngeal Airway: Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
he First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
The First Affiliated Hospital,Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Other trials for the same condition

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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07012772 on ClinicalTrials.gov ↗ ← All trials in China