CClinicalTrials.gg
Sign In
Not yet recruitingNCT07033702Updated Jun 24, 2025

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

An interventional study of Airway-Exchange Broncholaryngoscope (AEBLScope) in Tracheotomy Patients, Airway Management and Airway Disease, sponsored by University of Southern California. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by University of Southern California · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tracheotomy Patients
  • Airway Management
  • Airway Disease

Keywords

  • tracheostomy
  • bronchoscope
  • airway exchange
  • feasibility
  • safety
03

In context

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Airway-Exchange Broncholaryngoscope (AEBLScope)

Interventions

  • DeviceAirway-Exchange Broncholaryngoscope (AEBLScope)

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

06

What researchers measure

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.

    Time frame: During procedure, at time of intervention

Secondary outcomes

  1. Feasibility - Procedure duration

    Duration of the airway exchange procedure using the AEBLScope measured in seconds from device insertion to device withdrawal.

    Time frame: During procedure, at time of intervention

  2. Safety - Procedural complications

    Incidence of procedural complications related to use of the AEBLScope including but not limited to bleeding, airway trauma, patient intolerance, etc.

    Time frame: During procedure, at time of intervention

07

Study locations

2 sites
  • Keck Hospital of USC
    Los Angeles, California 90033, United States
    • Karla O'Dell, M.D. · Contact · karla.odell@med.usc.edu · 323-422-5790
    • Karla O'Dell, M.D. · Principal investigator
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
08

References and documents

Publications

  • 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. PubMed 25901542 ↗
  • 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. PubMed 15942375 ↗
  • 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. PubMed 17415123 ↗
  • 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. PubMed 24257382 ↗
  • 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. PubMed 17959966 ↗
  • 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. PubMed 26111264 ↗
  • 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/ PubMed 32310379 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07033702
Lead sponsor
University of Southern California
Responsible party
Karla O'Dell (Associate Professor of Otolaryngology - Head and Neck Surgery, University of Southern California) — Principal investigator
First posted
Jun 24, 2025
Start date
Sep 2025 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jun 24, 2025

Study contacts

Roger Boles, M.D.
Contact
roger.boles@med.usc.edu
626-755-3812
Karla O'Dell, M.D.
principal investigator · Univserity of Southern California

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Southern California

Start the discussion