AEBLScope for Tracheotomy

Not yet recruiting at 1 trial location

Overseen By Roger Boles, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: COPD, Restrictive lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Airway-Exchange Broncholaryngoscope (AEBLScope) to determine its safety and ease of use during routine tracheostomy tube changes. It is designed for individuals who have relied on a tracheostomy for over a month and do not require a ventilator or additional oxygen. Those who have undergone at least one tracheostomy tube change and are scheduled for another may be suitable candidates for this study. As an unphased study, this trial provides a unique opportunity to contribute to the development of innovative tools for tracheostomy care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AEBLScope is safe for tracheostomy tube exchanges?

Research shows that the AEBLScope is designed to enhance doctors' visibility when changing tracheostomy tubes. Tests in airway models demonstrated that it successfully changed tubes safely on the first attempt. These tests reported no serious side effects or problems, indicating a positive safety profile.

Since this is an early-stage study, information about its use in people remains limited. However, no major safety issues have emerged so far. Participants should know that while the AEBLScope appears promising, further research is necessary to fully understand its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AEBLScope is unique because it represents a novel approach for managing chronic tracheostomy tube-dependent patients. Unlike traditional methods that often require more invasive procedures or specialized settings, the AEBLScope allows for routine, in-office tracheostomy tube exchanges. This makes the process potentially quicker, more convenient, and less stressful for patients. Researchers are excited about this device because it could improve the quality of life for individuals with tracheostomies by simplifying their ongoing care.

What evidence suggests that the AEBLScope is effective for tracheostomy tube exchanges?

Research has shown that the Airway-Exchange Broncholaryngoscope (AEBLScope), used by participants in this trial, might make tracheostomy tube changes safer and more efficient. Studies have compared it to the Aintree Intubation Catheter in lab settings and suggest that the AEBLScope could be easier to use and more effective in some cases. Although limited data from actual patients exist, early results indicate it might help reduce complications during these procedures. Some studies suggest it could make the process faster and safer, but individual results may vary. Overall, further research is needed to confirm these benefits for a broader range of patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Karla O'Dell, M.D.

Principal Investigator

Univserity of Southern California

Are You a Good Fit for This Trial?

This trial is for adult outpatients who depend on a tracheostomy tube and require routine tube exchanges. Specific eligibility criteria are not provided, but typically participants must be in stable health aside from their airway management needs.

Inclusion Criteria

Able to provide informed consent

I am scheduled for a routine tracheostomy tube change in the doctor's office.

I am 18 years old or older.

Exclusion Criteria

Patients with airway tubes having an inner diameter less than 6.0 mm

Patients who are tracheostomy-dependent but cannot be orotracheally intubated

I currently have a respiratory infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo routine tracheostomy tube exchanges using the AEBLScope device

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airway-Exchange Broncholaryngoscope (AEBLScope)

Trial Overview

The study is testing the AEBLScope, a new tool designed to make tracheostomy tube exchanges safer and easier. It's a pilot study, meaning it's an early test to see if the device works well and doesn't cause problems during use.

How Is the Trial Designed?

Group I: Chronic Tracheostomy Tube-Dependent Patients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07033702

Study Details | NCT07033702 | Feasibility and Safety of the ...

This pilot study evaluates the safety and feasibility of a novel airway exchange broncholaryngoscope (AEBLScope) during routine tracheostomy ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40747740/

Randomized Crossover Comparison of the Airway ...

The purpose of this study was to compare the AEBLScope with the Aintree Intubation Catheter (Aintree) for AEPs in airway models. Methods: Thirty ...

3.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT07033702

Feasibility and Safety of the Airway Exchange ...

This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges. Official ...

4.

patlynk.com

patlynk.com/trial/NCT07033702

Airway Exchange Broncholaryngoscope Feasibility and ...

The study does not list specific risks or benefits, but the potential benefit is that it could make tracheostomy tube changes safer and quicker in the future.

5.

abea.net

abea.net/wp-content/uploads/2025/05/Session-1.pdf

Session 1

Of 31 surgeries, 6 complications (19.3%) occurred: airway edema requiring hospitalization, intubation due to respiratory failure, urgent tracheostomy, and 3 ...

6.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/lary.31583

Development of a Novel Airway‐Exchange ...

In two airway models using the AEBLScope, both tracheostomy and endotracheal tubes were successfully exchanged on first-pass attempt, and AECs ...