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

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.

NCT Number	NCT07063290
Lead Sponsor	Zhejiang University
Conditions	Pulmonary Infection, Pulmonary Nodule, Endotracheal Tumour, Bronchiectasis
Enrollment	104 participants
Start Date	2025-06-23
Primary Completion	2025-09-18 (estimated)
Study Completion	2025-09-18 (estimated)
Updated on ClinicalTrials.gov	2026-02-24