Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheomalacia
• Intervention / Treatment: Device: Dynamic Airway CT scan (DA-CT)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soumia Hammouda; Phone Number: 347-204-3293; Email: Soumia.Hammouda@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Tisch Hospital
    • New York, New York, United States, 10016
      • Recruiting
      • Fink Children's Ambulatory Center/Hassenfeld Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Eleanor Muise, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Tracheomalacia in Children
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Congenital Abnormalities; Musculoskeletal Diseases; Connective Tissue Diseases; Musculoskeletal Abnormalities; Cartilage Diseases; Tracheal Diseases; Tracheobronchomalacia; Tracheomalacia
• Other Study ID Numbers: 22-01279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Eleanor.Muise@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Eleanor.Muise@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes