Actively Recruiting
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
Led by RenJi Hospital · Updated on 2025-06-25
1200
Participants Needed
10
Research Sites
104 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 gastrointestinal endoscopy 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 our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.
CONDITIONS
Official Title
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Patients undergoing gastroendoscopy and/or colonoscopy
- Signed informed consent form
- ASA classification I or II
- Procedure duration estimated to be 45 minutes or less
You will not qualify if you...
- Contraindications to oropharyngeal airway ventilation such as bleeding disorders, mucosal damage, or anatomical issues
- Severe cardiac insufficiency with exercise capacity below 4 METs
- Severe kidney failure requiring dialysis
- Severe liver dysfunction
- Chronic obstructive pulmonary disease or other lung diseases requiring oxygen therapy
- Elevated intracranial pressure
- Upper respiratory infections
- Fever above 37.5°C
- Pregnancy or lactation
- Allergic reactions to propofol or medical equipment
- Urgent surgical intervention
- Polytrauma
- Preoperative oxygen saturation below 95% on room air
- BMI less than 18.5 or greater than 30
- History of substance abuse within past 2 years
- History of serious mental or neurological disorders
- Participation in other clinical trials
- Deemed ineligible by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
2
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
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3
Shangdong Provincial Qianfoshan Hospital
Jinan, Shandong, China, 250014
Actively Recruiting
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
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5
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
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6
Tongji Hospital Of Tongji University
Shanghai, Shanghai Municipality, China
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7
Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghia, China
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8
The First Affliated Hospital of Xi'an Jiangtong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
9
Tianjin Mediacal University General Hospital
Tianjin, Tianjin Municipality, China, 300052
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10
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
D
Diansan Su, Dr.
CONTACT
Y
Yuhan Zhang, B.S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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