Tracheotomy PatientsNCT07033702
Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)
A study testing Airway-Exchange Broncholaryngoscope (AEBLScope) in people with Tracheotomy Patients and Airway Management, run by University of Southern California at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheotomy Patients, Airway Management, Airway Disease
- What is being tested?
- Airway-Exchange Broncholaryngoscope (AEBLScope)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Keck Hospital of USC
Los Angeles, California, 90033
Karla O'Dell, M.D., 323-422-5790, karla.odell@med.usc.edu
Karla O'Dell, M.D.
Los Angeles General Medical Center
Los Angeles, California, 90033
Roger Boles, M.D., 626-755-3812, roger.boles@med.usc.edu
Roger Boles, M.D.
About this study
Official title: Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges
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.
Read the detailed description
The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.
- Conditions
- Tracheotomy Patients, Airway Management, Airway Disease
- Being tested
- Airway-Exchange Broncholaryngoscope (AEBLScope)
- Keywords
- tracheostomy, bronchoscope, airway exchange, feasibility, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway-Exchange Broncholaryngoscope (AEBLScope)Device
Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Tracheostomy Tube-Dependent Patients | Experimental | All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device. Receives: Device: Airway-Exchange Broncholaryngoscope (AEBLScope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure, at time of intervention
Secondary outcomes (2)
Feasibility - Procedure duration
Duration of the airway exchange procedure using the AEBLScope measured in seconds from device insertion to device withdrawal.
Measured: During procedure, at time of intervention
Safety - Procedural complications
Incidence of procedural complications related to use of the AEBLScope including but not limited to bleeding, airway trauma, patient intolerance, etc.
Measured: During procedure, at time of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tracheotomy PatientsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla O'Dell, University of Southern California
- Investigators
- Karla O'Dell, M.D., Principal investigator, Univserity of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033702
- Sponsor's protocol ID
- 23-06016
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Roddy DJ, Spaeder MC, Pastor W, Stockwell DC, Klugman D. Unplanned Extubations in Children: Impact on Hospital Cost and Length of Stay. Pediatr Crit Care Med. 2015 Jul;16(6):572-5. doi: 10.1097/PCC.0000000000000406.
PubMed 25901542Needham DM, Pronovost PJ. The importance of understanding the costs of critical care and mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1434-5. doi: 10.1097/01.ccm.0000166360.82336.75. No abstract available.
PubMed 15942375Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: a survey of otolaryngology training programs. Laryngoscope. 2007 Apr;117(4):573-6. doi: 10.1097/MLG.0b013e318030455a.
PubMed 17415123McLean S, Lanam CR, Benedict W, Kirkpatrick N, Kheterpal S, Ramachandran SK. Airway exchange failure and complications with the use of the Cook Airway Exchange Catheter(R): a single center cohort study of 1177 patients. Anesth Analg. 2013 Dec;117(6):1325-7. doi: 10.1213/ANE.0b013e3182a7cd3d.
PubMed 24257382Mort TC. Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. Anesth Analg. 2007 Nov;105(5):1357-62, table of contents. doi: 10.1213/01.ane.0000282826.68646.a1.
PubMed 17959966Mort TC, Braffett BH. Conventional Versus Video Laryngoscopy for Tracheal Tube Exchange: Glottic Visualization, Success Rates, Complications, and Rescue Alternatives in the High-Risk Difficult Airway Patient. Anesth Analg. 2015 Aug;121(2):440-8. doi: 10.1213/ANE.0000000000000825.
PubMed 26111264Ng J, Hohman MH, Agarwal A. Tracheostomy Tube Change. 2024 Feb 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555919/
PubMed 32310379
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges
- ClinicalTrials.gov ID
- NCT07033702
- Acronym / sponsor ID
- 23-06016
- Conditions
- Tracheotomy Patients, Airway Management, Airway Disease
- Keywords
- tracheostomy, bronchoscope, airway exchange, feasibility, safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Tracheostomy Tube-Dependent Patients | Experimental | Device: Airway-Exchange Broncholaryngoscope (AEBLScope)All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway-Exchange Broncholaryngoscope (AEBLScope)Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures. | Device | Chronic Tracheostomy Tube-Dependent Patients |
Primary outcome
Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope
Time frame: During procedure, at time of intervention
First-pass success defined as successful tracheostomy tube placement on initial attempt using the AEBLScope without need for repeat attempt or alternative instrumentation.
2 secondary outcomes
Feasibility - Procedure duration
Time frame: During procedure, at time of intervention
Safety - Procedural complications
Time frame: During procedure, at time of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 25901542Roddy DJ, Spaeder MC, Pastor W, Stockwell DC, Klugman D. Unplanned Extubations in Children: Impact on Hospital Cost and Length of Stay. Pediatr Crit Care Med. 2015 Jul;16(6):572-5. doi: 10.1097/PCC.0000000000000406.
- Background: PubMed 15942375Needham DM, Pronovost PJ. The importance of understanding the costs of critical care and mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1434-5. doi: 10.1097/01.ccm.0000166360.82336.75. No abstract available.
- Background: PubMed 17415123Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: a survey of otolaryngology training programs. Laryngoscope. 2007 Apr;117(4):573-6. doi: 10.1097/MLG.0b013e318030455a.
- Background: PubMed 24257382McLean S, Lanam CR, Benedict W, Kirkpatrick N, Kheterpal S, Ramachandran SK. Airway exchange failure and complications with the use of the Cook Airway Exchange Catheter(R): a single center cohort study of 1177 patients. Anesth Analg. 2013 Dec;117(6):1325-7. doi: 10.1213/ANE.0b013e3182a7cd3d.
- Background: PubMed 17959966Mort TC. Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. Anesth Analg. 2007 Nov;105(5):1357-62, table of contents. doi: 10.1213/01.ane.0000282826.68646.a1.
- Background: PubMed 26111264Mort TC, Braffett BH. Conventional Versus Video Laryngoscopy for Tracheal Tube Exchange: Glottic Visualization, Success Rates, Complications, and Rescue Alternatives in the High-Risk Difficult Airway Patient. Anesth Analg. 2015 Aug;121(2):440-8. doi: 10.1213/ANE.0000000000000825.
- Background: PubMed 32310379Ng J, Hohman MH, Agarwal A. Tracheostomy Tube Change. 2024 Feb 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555919/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karla O'Dell, M.D. principal investigator
Univserity of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway-Exchange Broncholaryngoscope (AEBLScope) in people with Tracheotomy Patients and Airway Management, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roger Boles, M.D. (626-755-3812, roger.boles@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope (time frame: During procedure, at time of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07033702, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.