Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

Tracheomalacia Clinical Trial

Official title:

Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028646
• Other study ID #: 22-01279
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Soumia Hammouda
• Phone: 347-204-3293
• Email: Soumia.Hammouda[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Tracheomalacia

Intervention

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

Locations

Country	Name	City	State
United States	Fink Children's Ambulatory Center/Hassenfeld Children's Center	New York	New York
United States	Tisch Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of dynamic narrowing on Flexible Bronchoscopy	Video recordings and images will be deidentified and reviewed by pediatric pulmonologists and scores averaged.; Severity of dynamic narrowing will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%.	Through study completion, an average of 1 year
Primary	Severity of Maximal Airway Change (MAC) on DA-CT	Severity of MAC will be classified as follows: mild: 33%-49%, moderate: 50%-66%, severe: >67%.; This outcome will be measured using the following equation: MAC = tracheal cross-sectional (CSA) at narrowed segment in inspiration/CSA of trachea at thoracic inlet in inspiration	Through study completion, an average of 1 year
Primary	Severity of Excessive dynamic airway collapse (EDAC) on DA-CT	Severity of EDAC will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%.; This outcome will be measured using the following equation: EDAC = CSA at airway segment in expiration/CSA at same location in inspiration	Through study completion, an average of 1 year
Secondary	Contrast-to-noise-ratio (CNR) of DA-CT scanners	This outcome will be measured using the following equation: CNR = (mean Hounsfield Units (HU) in the artery regions of interest (ROI) - mean HU in the tracheal air column ROI) / image noise inside the trachea.	Through study completion, an average of 1 year
Secondary	Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale	5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent	Through study completion, an average of 1 year
Secondary	Qualitative Analysis of DA-CT image noise based on 5-point Likert scale	5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent	Through study completion, an average of 1 year
Secondary	Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale	5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent	Through study completion, an average of 1 year
Secondary	Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale	5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent	Through study completion, an average of 1 year
Secondary	Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale	5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent	Through study completion, an average of 1 year
Secondary	Radiation exposure of DA-CT scanners	The effective dose (in mSv) will be automatically calculated with tissue weighting factors	Through study completion, an average of 1 year