Actively Recruiting
COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
Led by Zhejiang University · Updated on 2025-09-10
580
Participants Needed
3
Research Sites
33 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. This is particularly true for obese patients, who have a higher incidence of hypoxia. 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 and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.
CONDITIONS
Official Title
COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Body Mass Index (BMI) of 28 kg/m2 or higher
- American Society of Anesthesiologists (ASA) classification I or II
- Signed informed consent form
- Undergoing gastroendoscopy or colonoscopy procedure
- Estimated procedure duration of 45 minutes or less
You will not qualify if you...
- Contraindications to oropharyngeal airway ventilation such as bleeding disorders, risk of oral/nasal bleeding, mucosal damage, or anatomical issues preventing airway placement
- Severe heart failure with exercise capacity under 4 metabolic equivalents (METs)
- Severe kidney failure requiring dialysis
- Severe liver dysfunction
- Chronic obstructive pulmonary disease or other acute/chronic lung diseases requiring prolonged or intermittent oxygen therapy
- Increased intracranial pressure
- Upper respiratory infections affecting mouth, nose, or throat
- Fever above 37.5 degrees Celsius
- Pregnancy or breastfeeding
- Allergic reactions to sedatives like propofol or medical equipment adhesives
- Urgent surgery needed
- Multiple trauma injuries
- Preoperative oxygen saturation below 95% on room air
- BMI less than 28 kg/m2
- History of substance abuse of drugs or alcohol in the past 2 years
- History of mental or neurological disorders including depression, Parkinson's disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis
- Participation in other clinical trials
- Any condition making the patient unsuitable for this trial as determined by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
3
Zhejiang Cancer hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
D
Diansan Su, Chief Physician
CONTACT
M
Mingxia Xu
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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