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NCT Number: NCT06028646

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.

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Key information

Conditions

Tracheomalacia Cartilage Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Respiratory Tract Diseases Skin and Connective Tissue Diseases Tracheal Diseases Tracheobronchomalacia

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fink Children's Ambulatory Center/Hassenfeld Children's Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Airway CT scan (DA-CT)

Device

Patient will be asked to perform movements during the scan.

Primary outcomes

  1. 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%.

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Soumia Hammouda

CONTACT

[email protected]

347-204-3293

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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