NCT07063290

COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• 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 fiberoptic bronchoscopy 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 fiberoptic bronchoscopy under propofol sedation.

Conditions

• Pulmonary Infection
• Pulmonary Nodule
• Endotracheal Tumour
• Bronchiectasis

Interventions

Type	Name	Description
DEVICE	the COMBO Endoscopy Oropharyngeal Airway	Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Timeline

• Start date: 2025-06-23
• Primary completion: 2025-09-18
• Completion: 2025-09-18
• First posted: 2025-07-14
• Last updated: 2026-02-24

Locations

1 site across 1 country: China