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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age 18≤ Age ≤60.·Patients undergoing fiberoptic bronchoscopy.

• Patients have signed the informed consent form.

• The ASA classification ranges from I to II.

• The estimated duration of the procedure does not exceed 45 minutes.

Locations
Other Locations
China
The First Affliated Hospital, Zhejiang University School Of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Diansan Su
diansansu@yahoo.com
+8618616514088
Backup
Yeke Zhu
21618018@zju.edu.cn
+8613515815457
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2026-03
Participants
Target number of participants: 50
Treatments
Other: the COMBO Endoscopy Oropharyngeal Airway Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov