Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)
NCT ID: NCT07033702
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-09-30
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Chronic Tracheostomy Tube-Dependent Patients
All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.
Airway-Exchange Broncholaryngoscope (AEBLScope)
Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.
Interventions
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Airway-Exchange Broncholaryngoscope (AEBLScope)
Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Karla O'Dell
Associate Professor of Otolaryngology - Head and Neck Surgery
Principal Investigators
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Karla O'Dell, M.D.
Role: PRINCIPAL_INVESTIGATOR
Univserity of Southern California
Locations
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Keck Hospital of USC
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Roddy DJ, Spaeder MC, Pastor W, Stockwell DC, Klugman D. Unplanned Extubations in Children: Impact on Hospital Cost and Length of Stay. Pediatr Crit Care Med. 2015 Jul;16(6):572-5. doi: 10.1097/PCC.0000000000000406.
Needham DM, Pronovost PJ. The importance of understanding the costs of critical care and mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1434-5. doi: 10.1097/01.ccm.0000166360.82336.75. No abstract available.
Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: a survey of otolaryngology training programs. Laryngoscope. 2007 Apr;117(4):573-6. doi: 10.1097/MLG.0b013e318030455a.
McLean S, Lanam CR, Benedict W, Kirkpatrick N, Kheterpal S, Ramachandran SK. Airway exchange failure and complications with the use of the Cook Airway Exchange Catheter(R): a single center cohort study of 1177 patients. Anesth Analg. 2013 Dec;117(6):1325-7. doi: 10.1213/ANE.0b013e3182a7cd3d.
Mort TC. Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. Anesth Analg. 2007 Nov;105(5):1357-62, table of contents. doi: 10.1213/01.ane.0000282826.68646.a1.
Mort TC, Braffett BH. Conventional Versus Video Laryngoscopy for Tracheal Tube Exchange: Glottic Visualization, Success Rates, Complications, and Rescue Alternatives in the High-Risk Difficult Airway Patient. Anesth Analg. 2015 Aug;121(2):440-8. doi: 10.1213/ANE.0000000000000825.
Ng J, Hohman MH, Agarwal A. Tracheostomy Tube Change. 2024 Feb 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555919/
Other Identifiers
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23-06016
Identifier Type: -
Identifier Source: org_study_id
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