Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

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NYU Langone Health

Status

Enrolling

Conditions

Tracheomalacia

Treatments

Device: Dynamic Airway CT scan (DA-CT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06028646
22-01279

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Dynamic Airway CT scan (DA-CT)
Experimental group
Description:
All participants will have a DA-CT scan after flexible bronchoscopy has been performed.
Treatment:
Device: Dynamic Airway CT scan (DA-CT)

Trial contacts and locations

0

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Central trial contact

Soumia Hammouda

Data sourced from clinicaltrials.gov

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