TracheomalaciaNCT06028646
Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
A study testing Dynamic Airway CT scan (DA-CT) in people with Tracheomalacia, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Tracheomalacia
- What is being tested?
- Dynamic Airway CT scan (DA-CT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2023to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants 0-18 years old, with
- Clinically indicated flexible bronchoscopy has been performed
Who cannot join
- Pregnancy or breastfeeding
- Unable to undergo CT scanning without sedation
- Patients with tracheostomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fink Children's Ambulatory Center/Hassenfeld Children's Center
New York, New York, 10016
Tisch Hospital
New York, New York, 10016
About this study
The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.
- Conditions
- Tracheomalacia
- Being tested
- Dynamic Airway CT scan (DA-CT)
- Keywords
- Tracheomalacia in Children
- Medical subject headings
- Tracheomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Airway CT scan (DA-CT)Device
Patient will be asked to perform movements during the scan.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Airway CT scan (DA-CT) | Experimental | All participants will have a DA-CT scan after flexible bronchoscopy has been performed. Receives: Device: Dynamic Airway CT scan (DA-CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tracheomalacia Identified by DA-CT
Presence of tracheomalacia identified by the DA-CT procedure (binary).
Measured: Day 0 (Imaging Visit)
Secondary outcomes (7)
Image Noise in Tracheal Air Column Region of Interest (ROI)
Image noise was measured from CT attenuation values in the tracheal air-column region-of-interest. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
Measured: Day 0 (Imaging Visit)
Image Noise in Largest Imaged Mediastinal Artery ROI
Image noise was measured from CT attenuation values in the largest imaged mediastinal artery ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
Measured: Day 0 (Imaging Visit)
Image Noise in Entire Two-Dimensional Right Lung Measurement ROI
Image noise was measured from CT attenuation values in the entire 2-D right lung measurement ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
Measured: Day 0 (Imaging Visit)
Image Noise in Subcutaneous Fat ROI
Image noise was measured from CT attenuation values in the subcutaneous fat ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
Measured: Day 0 (Imaging Visit)
Image Noise in Ambient Air ROI
Image noise was measured from CT attenuation values in the ambient air ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
Measured: Day 0 (Imaging Visit)
Radiation Exposure of DA-CT Scanners
Dose length product (DLP), CT radiation dose metric representing the total energy delivered, measured in mGy·cm (milligray-centimeters) used to monitor overall radiation risk and establish reference levels
Measured: Day 0 (Imaging Visit)
Radiation Exposure of DA-CT Scanners
Size specific dose estimate (SSDE), computed tomography (CT) radiation dose metric (measured in mGy) that provides a more accurate estimation of the radiation absorbed by a patient compared to the traditional Volume CT Dose Index
Measured: Day 0 (Imaging Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start10 Aug 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TracheomalaciaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Muise, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028646
- Sponsor's protocol ID
- 22-01279
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2023
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Eleanor.Muise@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
- ClinicalTrials.gov ID
- NCT06028646
- Acronym / sponsor ID
- 22-01279
- Conditions
- Tracheomalacia
- Keywords
- Tracheomalacia in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Posted 20 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Airway CT scan (DA-CT) | Experimental | Device: Dynamic Airway CT scan (DA-CT)All participants will have a DA-CT scan after flexible bronchoscopy has been performed. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants 0-18 years old, with
- Clinically indicated flexible bronchoscopy has been performed
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- Unable to undergo CT scanning without sedation
- Patients with tracheostomy
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 |
|---|---|---|
| Dynamic Airway CT scan (DA-CT)Patient will be asked to perform movements during the scan. | Device | Dynamic Airway CT scan (DA-CT) |
Primary outcome
Number of Participants With Tracheomalacia Identified by DA-CT
Time frame: Day 0 (Imaging Visit)
Presence of tracheomalacia identified by the DA-CT procedure (binary).
7 secondary outcomes
Image Noise in Tracheal Air Column Region of Interest (ROI)
Time frame: Day 0 (Imaging Visit)
Image Noise in Largest Imaged Mediastinal Artery ROI
Time frame: Day 0 (Imaging Visit)
Image Noise in Entire Two-Dimensional Right Lung Measurement ROI
Time frame: Day 0 (Imaging Visit)
Image Noise in Subcutaneous Fat ROI
Time frame: Day 0 (Imaging Visit)
Image Noise in Ambient Air ROI
Time frame: Day 0 (Imaging Visit)
Radiation Exposure of DA-CT Scanners
Time frame: Day 0 (Imaging Visit)
Radiation Exposure of DA-CT Scanners
Time frame: Day 0 (Imaging Visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Eleanor.Muise@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Eleanor Muise, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Airway CT scan (DA-CT) in people with Tracheomalacia, run by NYU Langone Health 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Tracheomalacia Identified by DA-CT (time frame: Day 0 (Imaging Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.