Actively Recruiting
Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
Led by Zhejiang University · Updated on 2026-03-11
410
Participants Needed
5
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. 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.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
CONDITIONS
Official Title
Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body mass index (BMI) of 35 kg/m² or higher
- Undergoing gastroscopy or gastrointestinal endoscopy
- Procedure expected to last no more than 45 minutes
- Signed informed consent form
You will not qualify if you...
- Bleeding disorders or conditions making airway device placement unsafe
- Active upper respiratory infection or fever above 37.5°C
- Chronic obstructive pulmonary disease or pulmonary diseases needing oxygen therapy
- Preoperative oxygen saturation (SpO₂) 92% or below on room air
- Severe organ dysfunction such as cardiac, renal, hepatic failure, or increased intracranial pressure
- ASA physical status classification of IV or higher
- Pregnancy or breastfeeding
- Known allergy to sedatives like propofol or medical adhesives
- Multiple traumatic injuries
- Currently participating in another clinical trial
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Jinjiang Municipal Hospital
Jinjiang, Fujian, China, 362200
Actively Recruiting
3
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
4
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, China, 310000
Actively Recruiting
5
Taizhou Hospital of Zhejiang Province
Taizhou, 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
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here