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Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) | Clinical Trials | Clareo Health

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Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges

NCT07033702•University of Southern California

View on ClinicalTrials.gov

Summary

This pilot study evaluates the safety and feasibility of a novel airway exchange broncholaryngoscope (AEBLScope) during routine tracheostomy tube exchanges in chronically tracheostomy-dependent adult outpatients.

Detailed Description

The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•Chronically (\>1 month) tracheostomy-dependent outpatients
•Currently not requiring ventilatory or supplemental oxygen support
•Have undergone at least one prior tracheostomy tube exchange
•Scheduled for routine in-office tracheostomy tube exchange
•Able to provide informed consent

Exclusion Criteria

•Active respiratory infection
•Patients with airway tubes having an inner diameter less than 6.0 mm
•Patients with preexisting pulmonary conditions, including chronic obstructive pulmonary disease (COPD), restrictive lung disease, untreated pneumonia, or acute respiratory distress syndrome (ARDS)
•Patients who are tracheostomy-dependent but cannot be orotracheally intubated.
•Patients unable to provide informed consent and who have no legally authorized representative.

Locations (2)

Keck Hospital of USC

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

Key Dates

Start Date

September 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

June 24, 2025

Enrollment

ESTIMATED participants

Conditions

Tracheotomy PatientsAirway ManagementAirway Disease

Interventions

Airway-Exchange Broncholaryngoscope (AEBLScope)

DEVICE

Contacts

Roger Boles, M.D.

CONTACT

626-755-3812 roger.boles@med.usc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

Inclusion Criteria

Exclusion Criteria

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