Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT06028646

Conditions

Tracheomalacia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Dynamic Airway CT scan (DA-CT)

Study Details

Brief summary:

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.

Conditions

Tracheomalacia

Study ID

NCT06028646

Start date

Aug 10, 2023

Status verified date

Sep, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Dynamic Airway CT scan (DA-CT)

All participants will have a DA-CT scan after flexible bronchoscopy has been performed.

Interventions

Dynamic Airway CT scan (DA-CT)

Patient will be asked to perform movements during the scan.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Soumia Hammouda

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

Locations

Fink Children's Ambulatory Center/Hassenfeld Children's Center

Recruiting

New York, New York, United States, 10016

Tisch Hospital

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 26, 2024

Last verified

Sep, 2024

Keywords

  • Tracheomalacia in Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2024-09-26.