AEBLScope for Tracheotomy
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.12345Why 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.12356
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo routine tracheostomy tube exchanges using the AEBLScope device
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Airway-Exchange Broncholaryngoscope (AEBLScope)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor