Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

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.

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%.

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

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

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.

5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

Inclusion Criteria: Participants 0-18 years old, with Clinically indicated flexible bronchoscopy has been performed Exclusion Criteria: Pregnancy or breastfeeding Unable to undergo CT scanning without sedation Patients with tracheostomy

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.