NCT06081647

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypoxia
• Gastric Polyp
• Colon Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	the COMBO Endoscopy Oropharyngeal Airway	Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
DEVICE	Regular Nasal Cannula	Using regular nasal cannula for oxygenation.

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-12-27
• Completion: 2025-12-27
• First posted: 2023-10-13
• Last updated: 2025-06-25

Locations

10 sites across 1 country: China