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Airway Exchange Broncholaryngoscope Feasibility and Safety Study during Tracheostomy Tube Exchanges

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Study AimThis study examines if using the Airway Exchange Broncholaryngoscope (AEBLScope) during tracheostomy tube exchanges is feasible and safe.
What is being tested

Airway-Exchange Broncholaryngoscope (AEBLScope)

Device
Who is being recruted

Tracheotomy Patients

+ Airway Management
+ Airway Disease
Over 18 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Device Feasibility Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorUniversity of Southern California
Study ContactRoger Boles, M.D.
Last updated: June 24, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual 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.

Official TitlePilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges 
Principal SponsorUniversity of Southern California
Study ContactRoger Boles, M.D.
Last updated: June 24, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Tracheotomy Patients
Airway Management
Airway Disease
Criteria
6 inclusion criteria required to participate
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

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5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.
Study Objectives
Primary Objectives

First-pass success defined as successful tracheostomy tube placement on initial attempt using the AEBLScope without need for repeat attempt or alternative instrumentation.
Secondary Objectives

Duration of the airway exchange procedure using the AEBLScope measured in seconds from device insertion to device withdrawal.

Incidence of procedural complications related to use of the AEBLScope including but not limited to bleeding, airway trauma, patient intolerance, etc.

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
Suspended
Keck Hospital of USCLos Angeles, United StatesSee the location
Suspended
Los Angeles General Medical CenterLos Angeles, United States
Recruiting soon2 Study Centers