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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
Patient will be asked to perform movements during the scan.
Fink Children's Ambulatory Center/Hassenfeld Children's Center
New York, New York, United States
RECRUITINGTisch Hospital
New York, New York, United States
RECRUITINGSeverity 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%.
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.