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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.
Keck Hospital of USC
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
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
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
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
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