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Dynamic Airway CT Scan for Tracheomalacia in Children

N/A

Recruiting

Led By Eleanor Muise, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants 0-18 years old, with clinically indicated flexible bronchoscopy has been performed

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial studies whether Dynamic Airway CT can accurately diagnose tracheomalacia in children 0-18 without the need for a bronchoscopy. Results will help plan a more precise study.

Who is the study for?

This trial is for children aged 0-18 who may have tracheomalacia, a condition where the windpipe collapses when breathing. They must have already undergone a flexible bronchoscopy. It's not for pregnant or breastfeeding individuals, those who can't have a CT scan without sedation, or patients with a tracheostomy.Check my eligibility

What is being tested?

The study is testing Dynamic Airway CT scans (DA-CT) as a noninvasive way to diagnose tracheomalacia in kids. The goal is to see if DA-CT can be as good as bronchoscopy by looking at its accuracy and image quality while also checking how much radiation it exposes the kids to.See study design

What are the potential side effects?

Since this trial involves imaging rather than medication, side effects are minimal but may include discomfort from staying still during the scan and exposure to low levels of radiation typical of medical CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or younger and have had a flexible bronchoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Severity of Excessive dynamic airway collapse (EDAC) on DA-CT

Severity of Maximal Airway Change (MAC) on DA-CT

Severity of dynamic narrowing on Flexible Bronchoscopy

Secondary outcome measures

Contrast-to-noise-ratio (CNR) of DA-CT scanners

Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale

Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dynamic Airway CT scan (DA-CT)Experimental Treatment1 Intervention

All participants will have a DA-CT scan after flexible bronchoscopy has been performed.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,573 Total Patients Enrolled

Eleanor Muise, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation include participants aged 40 and above?

"This trial is seeking participants between infancy and late adolescence, up to the age of 18."

Answered by AI

Could I participate in this research study based on my current health and age status?

"This research study seeks to enroll 25 participants who suffer from tracheomalacia and are aged 0-18 years."

Answered by AI

Are there any vacancies for individuals wanting to participate in this clinical examination?

"Correct. Information on clinicaltrials.gov affirms that this medical research is currently seeking participants; it was first posted on August 10th 2023 and most recently updated September 1st 2023. The investigators aim to enlist 25 patients from two distinct locations."

Answered by AI

What are the prime aims of this investigation?

"The main aim of this study, which will take approximately one year to complete, is to assess the Severity of Maximal Airway Change (MAC) on DA-CT. Secondary goals include Qualitative Analysis of DA-CT Image Quality via a 5 point Likert scale from Very Poor - Excellent, Qualitative Analysis of DA-CT image noise using the same rating system and finally Qualitative Analysis for delineation of large airways also utilizing the five tier Likert system."

Answered by AI

What is the enrollment size for this clinical investigation?

"Correct. According to records found on clinicaltrials.gov, this research project is currently recruiting volunteers and has been since August 10th 2023. The study aims to enlist 25 participants over 2 sites before the last update on September 1st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

2023. "Dynamic Airway CT is Diagnostic for Tracheomalacia in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028646.