Airway Exchange Broncholaryngoscope Feasibility and Safety Study during Tracheostomy Tube Exchanges
This study examines if using the Airway Exchange Broncholaryngoscope (AEBLScope) during tracheostomy tube exchanges is feasible and safe.
Airway-Exchange Broncholaryngoscope (AEBLScope)
Device Feasibility Study
Summary
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.This study explores a new device called the AEBLScope, which is a specially designed, disposable tool helping doctors see more clearly when they change breathing tubes in patients. The goal is to test if this device is safe and easy to use during routine tracheostomy tube changes, which are procedures often done for patients who need help breathing through a tube in their neck. The study focuses on patients considered low-risk to ensure the device works well in a controlled setting before considering broader use. This research is important as it could lead to safer and more efficient tube changes, potentially reducing complications during the procedure. Participants in the study will undergo their regular tracheostomy tube exchange, but with the use of the AEBLScope to provide doctors with better visualization. This means the device will help the medical team see inside the airway more clearly while changing the tube. Throughout the study, researchers will monitor the process to ensure the device is safe and effective. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Los Angeles General Medical Center
Los Angeles, United States