Health TrialsbyHealthPanel

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

ConditionsTracheotomy PatientsAirway ManagementAirway Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Airway-Exchange Broncholaryngoscope (AEBLScope)

    Device

    Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Chronic Tracheostomy Tube-Dependent PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: