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RECRUITING
NCT06081647
NA

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. 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 our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.

Official title: The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2023-12-27

Completion Date

2025-12-27

Last Updated

2025-06-25

Healthy Volunteers

Yes

Interventions

DEVICE

the COMBO Endoscopy Oropharyngeal Airway

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

DEVICE

Regular Nasal Cannula

Using regular nasal cannula for oxygenation.

Locations (10)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Shangdong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Renji Hospital

Shanghai, Shanghai Municipality, China

Tongji Hospital Of Tongji University

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghia, China

The First Affliated Hospital of Xi'an Jiangtong University

Xi’an, Shanxi, China

Tianjin Mediacal University General Hospital

Tianjin, Tianjin Municipality, China

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China