Airway Disease, Airway Management, Tracheotomy Patients
Conditions
Keywords
tracheostomy, bronchoscope, airway exchange, feasibility, safety
Brief 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.
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.
Interventions
DEVICEAirway-Exchange Broncholaryngoscope (AEBLScope)
Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Procedure duration | During procedure, at time of intervention | Duration of the airway exchange procedure using the AEBLScope measured in seconds from device insertion to device withdrawal. |
| Safety - Procedural complications | 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. |
Countries
United States
Contacts
Primary ContactRoger Boles, M.D.
Outcome results
None listed