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Feasibility and Safety of the AEBLScope for Tracheostomy Tube Exchange

This study is testing a new device called the Airway-Exchange Broncholaryngoscope (AEBLScope) to see if it's safe and practical for routine tracheostomy tube exchanges. The AEBLScope is a modified flexible bronchoscope (a thin, lighted tube used to look inside the airways) that allows doctors to see what they are doing during the exchange. This study is for adults aged 18 and older who have had a tracheostomy (an opening in the neck to the windpipe) for over a month, do not need breathing support, and have had at least one tube exchange before. The main goal is to see how often the AEBLScope successfully helps with the first attempt at exchanging the tracheostomy tube. The study is currently enrolling up to 10 participants.

Study design
This is a single-arm pilot study, meaning all participants will receive the AEBLScope during their routine tracheostomy tube exchange. It aims to enroll 10 participants.
What's involved
You would participate during a routine in-office tracheostomy tube exchange procedure.
Compensation
Not stated in the trial record.
Follow-up
Feasibility is measured during the procedure, at the time of intervention. No further follow-up is specified.

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NCT07033702

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

Not Yet Recruiting
NAAges 18+InterventionalDevice feasibility
University of Southern California
~10 participants
Updated 2025-06-24 on ClinicalTrials.gov
What's tested:Airway-Exchange Broncholaryngoscope (AEBLScope)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope
Measured over During procedure, at time of intervention

Conditions

Tracheotomy Patients
Airway Management
Airway Disease

Explore related trials

Tracheotomy

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Karla O'Dell, M.D. · PRINCIPAL_INVESTIGATOR · Univserity of Southern California

Who to contact

Roger Boles, M.D.
[email protected]
626-755-3812
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScopeDuring procedure, at time of intervention

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