Actively Recruiting
COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
Led by Zhejiang University · Updated on 2025-06-24
50
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of the COMBO Endoscopy Oropharyngeal Airway device to reduce the occurrence of low oxygen levels (hypoxia) during sedation for patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). The study targets patients with conditions such as choledocholithiasis with cholecystitis with obstruction, obstructive jaundice, pancreatitis, and cholelithiasis. It is conducted under phase 2 clinical trial conditions to explore this new device's role in improving patient safety during the procedure. Participants will use the COMBO Endoscopy Oropharyngeal Airway, a multifunctional device designed to provide oxygen support, protect the airways, and monitor breathing during sedated ERCP procedures. The device integrates capnography monitoring, bite block protection, oxygen delivery, and airway management tailored specifically for endoscopic procedures. This device group represents the experimental arm of the study. During the hospital stay, expected to last about 2 hours, patients will be closely monitored to measure the frequency of hypoxia, sub-clinical respiratory depression, and severe hypoxia. Researchers will observe and record these breathing-related outcomes throughout the procedure and recovery. The study includes safety evaluations and continuous monitoring to assess the device's impact on patient oxygen levels during sedation.
CONDITIONS
Brief Title
COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ASA classification from I to III
- Signed informed consent form
- Scheduled to undergo sedated ERCP examination
- Estimated procedure duration does not exceed 45 minutes
You will not qualify if you...
- Coagulation disorders or bleeding tendency making airway management unfeasible
- Severe cardiac dysfunction with less than 4 METs
- Severe renal insufficiency requiring preoperative dialysis
- Child-Pugh class C liver disease
- Chronic obstructive pulmonary disease or other pulmonary diseases requiring long-term oxygen therapy
- Increased intracranial pressure
- Upper respiratory tract infections
- Fever with core temperature above 37.5°C
- Confirmed pregnancy or current breastfeeding
- Allergy to sedatives like propofol or medical adhesives
- Emergency procedures
- Multiple trauma injuries
- Preoperative peripheral oxygen saturation below 95% on room air
- Body mass index below 18.5 or above 30 kg/m²
- Participation in other clinical trials
- Other conditions deemed ineligible by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to the procedure
Duration - Up to 45 minutes during the procedure
Participants use the COMBO Endoscopy Oropharyngeal Airway device during their sedated ERCP procedure for oxygenation.
1 visit (in-person) on the day of the procedure
Duration - Approximately 2 hours during hospital stay
Participants are monitored for respiratory status and oxygen levels during the hospital stay after the procedure.
Continuous monitoring during the hospital stay post-procedure
Trial Site Locations
Total: 2 locations
1
he First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
D
DiSan Head of Anesthesiology, PhD
L
Lianjuan Sun, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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