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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Airway CT scan (DA-CT) | Experimental | All participants will have a DA-CT scan after flexible bronchoscopy has been performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Airway CT scan (DA-CT) | Device | Patient will be asked to perform movements during the scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of dynamic narrowing on Flexible Bronchoscopy | Video recordings and images will be deidentified and reviewed by pediatric pulmonologists and scores averaged. Severity of dynamic narrowing will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%. | Through study completion, an average of 1 year |
| Severity of Maximal Airway Change (MAC) on DA-CT | Severity of MAC will be classified as follows: mild: 33%-49%, moderate: 50%-66%, severe: >67%. This outcome will be measured using the following equation: MAC = tracheal cross-sectional (CSA) at narrowed segment in inspiration/CSA of trachea at thoracic inlet in inspiration | Through study completion, an average of 1 year |
| Severity of Excessive dynamic airway collapse (EDAC) on DA-CT | Severity of EDAC will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%. This outcome will be measured using the following equation: EDAC = CSA at airway segment in expiration/CSA at same location in inspiration | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-to-noise-ratio (CNR) of DA-CT scanners | This outcome will be measured using the following equation: CNR = (mean Hounsfield Units (HU) in the artery regions of interest (ROI) - mean HU in the tracheal air column ROI) / image noise inside the trachea. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soumia Hammouda | Contact | 347-204-3293 | Soumia.Hammouda@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Eleanor Muise, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fink Children's Ambulatory Center/Hassenfeld Children's Center | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Eleanor.Muise@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D055090 | Tracheomalacia |
| ID | Term |
|---|---|
| D055089 | Tracheobronchomalacia |
| D002357 | Cartilage Diseases |
| D009140 | Musculoskeletal Diseases |
| D014133 | Tracheal Diseases |
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| Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale |
5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent |
| Through study completion, an average of 1 year |
| Qualitative Analysis of DA-CT image noise based on 5-point Likert scale | 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent | Through study completion, an average of 1 year |
| Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale | 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent | Through study completion, an average of 1 year |
| Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale | 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent | Through study completion, an average of 1 year |
| Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale | 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent | Through study completion, an average of 1 year |
| Radiation exposure of DA-CT scanners | The effective dose (in mSv) will be automatically calculated with tissue weighting factors | Through study completion, an average of 1 year |
| Tisch Hospital | Recruiting | New York | New York | 10016 | United States |
| D012140 |
| Respiratory Tract Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |