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RECRUITING
NCT06796764
NA

COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2025-04-11

Completion Date

2025-12-04

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DEVICE

the COMBO Endoscopy Oropharyngeal Airway Group

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

DEVICE

Regular Nasal Cannula

Using regular nasal cannula for oxygenation.

Locations (3)

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