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NCT Number: NCT07033702

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

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.

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Key information

Conditions

Tracheotomy Patients Airway Disease Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Hospital of USC, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Airway-Exchange Broncholaryngoscope (AEBLScope)

Device

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

Primary outcomes

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

    Time frame: During 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.

Secondary outcomes

  1. Feasibility - Procedure duration

    Time frame: During procedure, at time of intervention

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

  2. Safety - Procedural complications

    Time frame: During procedure, at time of intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Roger Boles, M.D.

CONTACT

[email protected]

626-755-3812

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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