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Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial
Led by Zhejiang University · Updated on 2026-03-11
410
Participants Needed
5
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying morbidly obese patients, defined as those with a body mass index (BMI) of 35 or higher, undergoing sedated gastrointestinal endoscopy. The study aims to find out if using a combination of the COMBO Endoscopy Oropharyngeal Airway device and High-Flow Nasal Cannula oxygenation can reduce episodes of low oxygen levels (hypoxemia) during these procedures, a common issue exceeding 40% in this group. Participants are randomly assigned to one of two groups: one group receives oxygen through the High-Flow Nasal Cannula along with the COMBO Endoscopy Oropharyngeal Airway device, which also supports airway management and monitoring; the other group receives only the High-Flow Nasal Cannula oxygenation. The procedure duration is expected to be no longer than 45 minutes. This is a multicenter, randomized, controlled trial sponsored by Zhejiang University. During the hospital stay, typically around 2 hours, patients will be monitored for occurrences of hypoxemia and related respiratory issues such as sub-clinical respiratory depression and severe hypoxemia. The study tracks these outcomes throughout the procedure and recovery period to evaluate the effectiveness of the combination device and oxygen support. Safety and any adverse events will also be monitored closely during this time.
CONDITIONS
Brief 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/m8 or higher
- Undergoing gastroscopy or gastrointestinal endoscopy
- Estimated procedure duration of 45 minutes or less
- Signed informed consent form
You will not qualify if you...
- Coagulation disorders or bleeding risks that make airway placement unsafe
- Active upper respiratory infection or fever over 37.56C
- Chronic or acute pulmonary diseases requiring oxygen therapy or low oxygen saturation (SpO2 8% or less) on room air
- Severe organ dysfunction such as cardiac insufficiency, renal failure requiring dialysis, severe liver issues, increased intracranial pressure, or ASA physical status IV or higher
- Confirmed pregnancy or breastfeeding
- Known allergy to sedatives or medical adhesives
- Multiple traumatic injuries
- Current participation in another clinical trial
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure duration of up to 45 minutes
Participants undergo sedated gastrointestinal endoscopy using either the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation or High-Flow Nasal Cannula Oxygenation alone.
1 procedure visit (in-person)
Duration - Approximately 2 hours
Participants are monitored for respiratory status and oxygen levels during their hospital stay after the procedure.
1 to 2 post-procedure monitoring visits (in-person)
Trial Site Locations
Total: 5 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000
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2
Jinjiang Municipal Hospital
Jinjiang, Fujian, China, 362200
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3
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
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4
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, China, 310000
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5
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 310000
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Research Team
D
Diansan Su, Chief Physician
M
Mingxia Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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