Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
ConditionTracheomalacia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants 0-18 years old, with
Clinically indicated flexible bronchoscopy has been performed
Disqualifiers
Pregnancy or breastfeeding
Unable to undergo CT scanning without sedation
Patients with tracheostomy
Trial design
Design model
Single group
Treatments tested in this trial
Dynamic Airway CT scan (DA-CT)
DevicePatient will be asked to perform movements during the scan.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Dynamic Airway CT scan (DA-CT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
Through study completion, an average of 1 year2
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 year3
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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov