Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

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)

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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)