Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

University of Southern California

Status: Not yet enrolling

Conditions: Airway Disease; Tracheotomy Patients; Airway Management

Treatments: Device: Airway-Exchange Broncholaryngoscope (AEBLScope)

Study type: Interventional

Funder types: Other

Identifiers

NCT07033702

23-06016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Chronic Tracheostomy Tube-Dependent Patients

Experimental group

Description:

All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.

Treatment:

Device: Airway-Exchange Broncholaryngoscope (AEBLScope)