Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges
University of Southern California
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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: * 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 pneumoni…
Interventions
- DeviceAirway-Exchange Broncholaryngoscope (AEBLScope)
Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.
Locations (2)
- Keck Hospital of USCLos Angeles, California
- Los Angeles General Medical CenterLos Angeles, California