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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the COMBO Endoscopy Oropharyngeal Airway device to reduce hypoxia in obese patients undergoing gastrointestinal endoscopy with sedation using propofol. Hypoxia is a common problem during these procedures, especially among obese individuals. This trial is a multicenter, randomized, controlled clinical study led by Zhejiang University to assess the safety and effectiveness of this new device in this high-risk group. Participants are randomly assigned to one of two groups: one group uses the COMBO Endoscopy Oropharyngeal Airway for oxygenation, while the other group uses a regular nasal cannula. Both devices support oxygen delivery during endoscopy and sedation. The procedure duration is limited to 45 minutes, and the study focuses on patients with a BMI of 28 kg/m² or higher. During the hospital stay, which averages about two hours, participants will be monitored for episodes of hypoxia and respiratory depression. Researchers will assess oxygen saturation levels and follow patients throughout the procedure and recovery period. Safety and efficacy outcomes will be recorded, including the incidence of oxygen desaturation events. The study will continue until December 2025.
CONDITIONS
Brief 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 between 18 and 70 years
- Body mass index (BMI) of 28 kg/m² or higher
- ASA classification of I or II
- Signed informed consent form
- Undergoing gastrointestinal endoscopy or colonoscopy
- Procedure duration expected to be 45 minutes or less
You will not qualify if you...
- Contraindications to oropharyngeal airway use, such as bleeding disorders or anatomical issues
- Severe heart failure with exercise capacity under 4 metabolic equivalents (METs)
- Severe kidney failure requiring dialysis
- Severe liver dysfunction
- Chronic obstructive pulmonary disease (COPD) or ongoing pulmonary conditions needing oxygen therapy
- High intracranial pressure
- Upper respiratory tract infections
- Fever above 37.5°C
- Pregnancy or breastfeeding
- Allergic reactions to sedatives like propofol or medical equipment
- Urgent surgery required
- Multiple injuries (polytrauma)
- Preoperative oxygen saturation below 95% on room air
- BMI less than 28 kg/m²
- History of substance abuse in past 2 years
- History of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 hours during hospital stay
Participants receive oxygenation using either the COMBO Endoscopy Oropharyngeal Airway or a regular nasal cannula during sedated gastrointestinal endoscopy or colonoscopy.
1 procedure visit (in-person)
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
M
Mingxia Xu
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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