Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
- Conditions
- Tracheomalacia
- Interventions
- Device: Dynamic Airway CT scan (DA-CT)
- Registration Number
- NCT06028646
- Lead Sponsor
- NYU Langone Health
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- Participants 0-18 years old, with
- Clinically indicated flexible bronchoscopy has been performed
- Pregnancy or breastfeeding
- Unable to undergo CT scanning without sedation
- Patients with tracheostomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dynamic Airway CT scan (DA-CT) Dynamic Airway CT scan (DA-CT) All participants will have a DA-CT scan after flexible bronchoscopy has been performed.
- Primary Outcome Measures
Name Time Method Severity of dynamic narrowing on Flexible Bronchoscopy Through study completion, an average of 1 year 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 Excessive dynamic airway collapse (EDAC) on DA-CT Through study completion, an average of 1 year 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 inspirationSeverity of Maximal Airway Change (MAC) on DA-CT Through study completion, an average of 1 year 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
- Secondary Outcome Measures
Name Time Method Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale Through study completion, an average of 1 year 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
Qualitative Analysis of DA-CT image noise based on 5-point Likert scale Through study completion, an average of 1 year 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale Through study completion, an average of 1 year 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
Radiation exposure of DA-CT scanners Through study completion, an average of 1 year The effective dose (in mSv) will be automatically calculated with tissue weighting factors
Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale Through study completion, an average of 1 year 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
Contrast-to-noise-ratio (CNR) of DA-CT scanners Through study completion, an average of 1 year 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.Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale Through study completion, an average of 1 year 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
Trial Locations
- Locations (2)
Tisch Hospital
🇺🇸New York, New York, United States
Fink Children's Ambulatory Center/Hassenfeld Children's Center
🇺🇸New York, New York, United States