Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

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

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.

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.