NCT06796764

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxia
• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-11
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2025-01-28
• Last updated: 2025-09-10

Locations

3 sites across 1 country: China