Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

September 25, 2024 updated by: NYU Langone Health
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Through study completion, an average of 1 year

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
Time Frame: Through study completion, an average of 1 year

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
Time Frame: Through study completion, an average of 1 year

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
Time Frame: Through study completion, an average of 1 year

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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
The effective dose (in mSv) will be automatically calculated with tissue weighting factors
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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