Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

Study Overview
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Brief Summary
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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.

Official Title
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Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

Conditions
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Tracheomalacia

Intervention / Treatment
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* Device: Dynamic Airway CT scan (DA-CT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Airway CT scan (DA-CT)<br>All participants will have a DA-CT scan after flexible bronchoscopy has been performed. | Device: Dynamic Airway CT scan (DA-CT)<br>* Patient will be asked to perform movements during the scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheomalacia in Children