Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2023
CompletedFirst Submitted
Initial submission to the registry
September 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedSeptember 26, 2024
September 1, 2024
1.9 years
September 1, 2023
September 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Contrast-to-noise-ratio (CNR) of DA-CT scanners
Through study completion, an average of 1 year
Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale
Through study completion, an average of 1 year
Qualitative Analysis of DA-CT image noise based on 5-point Likert scale
Through study completion, an average of 1 year
Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale
Through study completion, an average of 1 year
Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale
Through study completion, an average of 1 year
- +2 more secondary outcomes
Study Arms (1)
Dynamic Airway CT scan (DA-CT)
EXPERIMENTALAll participants will have a DA-CT scan after flexible bronchoscopy has been performed.
Interventions
Patient will be asked to perform movements during the scan.
Eligibility Criteria
You may qualify if:
- Participants 0-18 years old, with
- Clinically indicated flexible bronchoscopy has been performed
You may not qualify if:
- Pregnancy or breastfeeding
- Unable to undergo CT scanning without sedation
- Patients with tracheostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fink Children's Ambulatory Center/Hassenfeld Children's Center
New York, New York, 10016, United States
Tisch Hospital
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleanor Muise, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2023
First Posted
September 8, 2023
Study Start
August 10, 2023
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
September 26, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.