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
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- ASA classification between I and III
- Signed informed consent form
- Scheduled for sedated ERCP examination
- Estimated procedure duration of 45 minutes or less
You will not qualify if you...
- Coagulation disorders or bleeding tendencies affecting airway management
- 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 oxygen therapy
- Increased intracranial pressure
- Upper respiratory tract infections
- Fever with core temperature above 37.5 0C
- Confirmed pregnancy or breastfeeding
- Allergy to sedatives like propofol or medical adhesives
- Emergency procedures
- Multiple trauma injuries
- Preoperative oxygen saturation below 95% on room air
- Body mass index below 18.5 or above 30 kg/m2
- Current 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
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
CONTACT
L
Lianjuan Sun, Master
CONTACT
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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