Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

Purpose

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.

Condition

  • Tracheomalacia

Eligibility

Eligible Ages
Between 0 Years and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dynamic Airway CT scan (DA-CT) 		All participants will have a DA-CT scan after flexible bronchoscopy has been performed.
  • Device: Dynamic Airway CT scan (DA-CT)
    Patient will be asked to perform movements during the scan.

Recruiting Locations

Fink Children's Ambulatory Center/Hassenfeld Children's Center
New York, New York 10016

Tisch Hospital
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Soumia Hammouda
347-204-3293
Soumia.Hammouda@nyulangone.org