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COMBO Endoscopy Oropharyngeal Airway in Sedated Gastrointestinal Endoscopy for Obese Patients | Clinical Trials | Clareo Health

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COMBO Endoscopy Oropharyngeal Airway in Sedated Gastrointestinal Endoscopy for Obese Patients

NCT06804876•Zhejiang University

View on ClinicalTrials.gov

Summary

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 of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18≤ Age ≤70.
•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

•Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
•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.
+8 more criteria

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

February 4, 2025

Primary Completion Date

March 26, 2025

Completion Date

March 26, 2025

Last Updated

May 21, 2025

Enrollment

107

ACTUAL participants

Conditions

HypoxiaEsophageal CancerColon CancerGastric Cancer

Interventions

the COMBO Endoscopy Oropharyngeal Airway

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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COMBO Endoscopy Oropharyngeal Airway in Sedated Gastrointestinal Endoscopy for Obese Patients

Inclusion Criteria

Exclusion Criteria

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