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Recruiting NCT06028646

Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

No phase Interventional Tracheomalacia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dynamic Airway CT scan (DA-CT).
Who it may be relevant to
Registry conditions: Tracheomalacia. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Dynamic Airway CT scan (DA-CT)
    Patient will be asked to perform movements during the scan.

Primary outcome measures

  • Severity of dynamic narrowing on Flexible Bronchoscopy [Time frame: Through study completion, an average of 1 year]
  • Severity of Maximal Airway Change (MAC) on DA-CT [Time frame: Through study completion, an average of 1 year]
  • Severity of Excessive dynamic airway collapse (EDAC) on DA-CT [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (7)
  • Contrast-to-noise-ratio (CNR) of DA-CT scanners [Time frame: Through study completion, an average of 1 year]
  • Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale [Time frame: Through study completion, an average of 1 year]
  • Qualitative Analysis of DA-CT image noise based on 5-point Likert scale [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 [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 [Time frame: Through study completion, an average of 1 year]
  • Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale [Time frame: Through study completion, an average of 1 year]
  • Radiation exposure of DA-CT scanners [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 2 centers
  • Fink Children's Ambulatory Center/Hassenfeld Children's Center — New York
  • Tisch Hospital — New York

Identifiers

NCT: NCT06028646 · 22-01279

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗