COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
NCT ID: NCT06796764
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
580 participants
INTERVENTIONAL
2025-04-11
2025-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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the COMBO Endoscopy Oropharyngeal Airway Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
the COMBO Endoscopy Oropharyngeal Airway Group
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Regular Nasal Cannula Group
In this group, patients use the regular nasal cannula for oxygenation.
Regular Nasal Cannula
Using regular nasal cannula for oxygenation.
Interventions
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the COMBO Endoscopy Oropharyngeal Airway Group
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Regular Nasal Cannula
Using regular nasal cannula for oxygenation.
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 28 kg/m².
* The ASA classification ranges from I to II.
* Patients have signed the informed consent form.
* Patients undergoing gastroendoscopy and colonoscopy procedure.
* The estimated duration of the procedure does not exceed 45 minutes.
Exclusion Criteria
* Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
* Profound renal insufficiency necessitating preoperative dialysis.
* A confirmed severe liver dysfunction.
* Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
* Elevated intracranial pressure.
* Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
* Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
* Pregnancy or lactation.
* Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
* Urgent surgical intervention.
* Polytrauma.
* Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
* BMI\<28 kg/m².
* Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
* Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
* Presently engaged in concurrent participation in additional clinical trials.
* Patients considered ineligible by researchers for inclusion in this clinical trial.
18 Years
70 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Responsible Party
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Diansan Su
Chair of the Department of Anesthesiology
Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZJU2025B0065
Identifier Type: -
Identifier Source: org_study_id
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