NCT07175155

Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients

Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. 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.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.

Conditions

• Hypoxemia
• Esophageal Cancer
• Morbidly Obese Patients
• Gastric Cancer

Interventions

Type	Name	Description
DEVICE	COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation	Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients
DEVICE	High-Flow Nasal Cannula Oxygenation	In this group, patients use high-flow nasal cannula oxygenation

Timeline

• Start date: 2025-10-24
• Primary completion: 2027-08-20
• Completion: 2027-08-20
• First posted: 2025-09-16
• Last updated: 2026-03-11

Locations

5 sites across 1 country: China