COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial
NCT07063290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2026-02-24
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
- DEVICE
-
the COMBO Endoscopy Oropharyngeal Airway
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Sponsors & Collaborators
-
Zhejiang University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-23
- Primary Completion
- 2025-09-18
- Completion
- 2025-09-18
Countries
- China
Study Locations
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