Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

NCT07033702 | Not Yet Recruiting FDA Device

• 1 other identifier: 23-06016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tracheotomy Patients; Airway Management; Airway Disease

Keywords

tracheostomy; bronchoscope; airway exchange; feasibility; safety

Outcome Measures

Primary Outcomes (1)

• Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope

  First-pass success defined as successful tracheostomy tube placement on initial attempt using the AEBLScope without need for repeat attempt or alternative instrumentation.

  During procedure, at time of intervention

Secondary Outcomes (2)

• Feasibility - Procedure duration

  During procedure, at time of intervention

• Safety - Procedural complications

  During procedure, at time of intervention

Study Arms (1)

Chronic Tracheostomy Tube-Dependent Patients

EXPERIMENTAL

All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.

Device: Airway-Exchange Broncholaryngoscope (AEBLScope)

Interventions

Airway-Exchange Broncholaryngoscope (AEBLScope) DEVICE

Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.

Chronic Tracheostomy Tube-Dependent Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (7)

• 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.

  PMID: 25901542 BACKGROUND

• 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.

  PMID: 15942375 BACKGROUND

• 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.

  PMID: 17415123 BACKGROUND

• 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.

  PMID: 24257382 BACKGROUND

• 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.

  PMID: 17959966 BACKGROUND

• 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.

  PMID: 26111264 BACKGROUND

• 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/

  PMID: 32310379 BACKGROUND

Study Officials

• Karla O'Dell, M.D.

  Univserity of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger Boles, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)