Dynamic Airway CT Scan for Tracheomalacia in Children

Recruiting at 1 trial location

Overseen By Soumia Hammouda

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Dynamic Airway CT scan (DA-CT) for tracheomalacia in children?

Research shows that Dynamic CT can provide real-time information and detailed images of airway narrowing, which helps in understanding and managing conditions like tracheomalacia in children. This technique is non-invasive and uses low radiation doses, making it a safe and effective way to evaluate airway issues. ^{1 2 3 4 5}

Is the Dynamic Airway CT Scan safe for children?

Dynamic Airway CT Scans have been used in children without anesthesia, showing similar radiation doses to routine chest CT scans, which are generally considered safe. However, motion artifacts (blurring due to movement) were present in some cases, and the technique requires careful handling to avoid pitfalls like improper tube placement. ^{1 2 4 6 7}

How is the Dynamic Airway CT Scan treatment different from other treatments for tracheomalacia in children?

The Dynamic Airway CT Scan is unique because it provides real-time, non-invasive imaging of the airway without the need for anesthesia or intubation, unlike traditional methods like bronchoscopy. This allows for a more accurate assessment of airway narrowing in children with tracheomalacia. ^{1 3 7 8 9}

Research Team

Eleanor Muise, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

I need sedation to have a CT scan.

Pregnancy or breastfeeding

You have a tracheostomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Participants undergo a Dynamic Airway CT scan (DA-CT) after flexible bronchoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

1 year

Treatment Details

Interventions

• Dynamic Airway CT scan (DA-CT)

Trial Overview 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.

Participant Groups

Group I: Dynamic Airway CT scan (DA-CT) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Volumetric CT is a non-invasive and effective method for assessing the pediatric airway, particularly for conditions like tracheobronchomalacia, without the need for intubation or patient cooperation.

This technique provides a four-dimensional view of the airway at a significantly lower radiation dose compared to traditional dynamic CT imaging, making it safer for infants with complex respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic volumetric computed tomographic assessment of the young paediatric airway: Initial experience of rapid, non-invasive, four-dimensional technique. Tan, JZ., Crossett, M., Ditchfield, M.[2022]

Ultralow dose dynamic expiratory CT (ULD) for evaluating tracheomalacia resulted in a very low average effective radiation dose of 0.08 mSv, which is a 95% reduction compared to typical dose CT, making it a safer imaging option.

Despite a slight decrease in image quality compared to typical dose CT, ULD maintained diagnostic quality for all studies, with better image quality observed at 100 kVp compared to 80 kVp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultralow Dose Dynamic Expiratory Computed Tomography for Evaluation of Tracheomalacia. Cohen, SL., Ben-Levi, E., Karp, JB., et al.[2019]

Dynamic computed tomography (dCT) effectively diagnosed tracheobronchomalacia (TBM) in 53% of the 70 premature infants studied, providing critical insights into airway narrowing and severity levels.

The findings from dCT led to significant management changes in patient care, including adjustments in ventilation strategies and medication, highlighting its role as a valuable noninvasive tool for guiding treatment in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic computed tomography for evaluation of tracheobronchomalacia in premature infants with bronchopulmonary dysplasia. Pugh, CP., Ali, S., Agarwal, A., et al.[2023]

A novel 320-row multidetector computed tomography (MDCT) technique effectively diagnosed tracheomalacia in all 6 adult patients studied, revealing that the proximal trachea collapses later during expiration compared to the distal trachea.

The most common site of airway collapse was at the aortic arch, and the imaging technique provided a detailed assessment of airway dynamics while maintaining a relatively low radiation dose, making it a promising method for evaluating tracheomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic airway evaluation with volume CT: initial experience. Wagnetz, U., Roberts, HC., Chung, T., et al.[2019]

In a study of 30 pediatric patients (15 with tracheomalacia and 15 without), those with tracheomalacia exhibited significantly higher severity and frequency of air trapping, indicating a clear difference in lung function between the two groups.

All patients with tracheomalacia showed air trapping, with a median score of 5.0, compared to a median score of 3.0 in the comparison group, suggesting that tracheomalacia is associated with more severe respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory volumetric MDCT evaluation of air trapping in pediatric patients with and without tracheomalacia. Lee, EY., Tracy, DA., Bastos, Md., et al.[2016]

In a study of 33 children using dynamic 4-D CT imaging of the airways, 61% were found to have tracheobronchomalacia, indicating that this imaging technique is effective for diagnosing airway collapse without the need for anesthesia.

The mean effective radiation dose for dynamic 4-D CT was comparable to routine chest CT scans, at 1.0 mSv, suggesting that this method is a safe imaging option for children, with most cases of tracheobronchomalacia managed successfully through conservative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique, pitfalls, quality, radiation dose and findings of dynamic 4-dimensional computed tomography for airway imaging in infants and children. Andronikou, S., Chopra, M., Langton-Hewer, S., et al.[2020]

Dynamic volumetric computed tomography angiography (DV-CTA) can effectively diagnose tracheomalacia in children without the need for sedation or respiratory manipulation, making it a safer alternative to traditional bronchoscopy.

In a study of 32 children, DV-CTA showed excellent agreement with bronchoscopy results for diagnosing tracheomalacia, with a correlation coefficient of κ = 0.81, which improved to κ = 0.91 when studies were conducted within 30 days of each other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Volumetric Computed Tomography Angiography is an Effective Method to Evaluate Tracheomalacia in Children. Koenigs, M., Young, C., Lillis, A., et al.[2023]

In a study of 28 children suspected of tracheomalacia (TM), flexible bronchoscopy confirmed TM in 26 cases, highlighting the effectiveness of this method for diagnosis.

Multi-detector CT (MDCT) was found to be a reliable alternative for diagnosing TM, with a recommended cut-off for the cross-sectional area ratio (CSR) of ≤0.7, achieving 84.6% sensitivity and 100% specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helical multi-detector CT scan as a tool for diagnosing tracheomalacia in children. Douros, K., Kremmydas, G., Grammeniatis, V., et al.[2020]

Advancements in multidetector computed tomography (MDCT) technology have significantly improved the noninvasive assessment of large airways in children, allowing for better diagnosis of airway diseases.

The 320-MDCT scanner offers detailed anatomical and functional information, making it particularly useful for evaluating dynamic airway conditions like tracheobronchomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidetector computed tomography of pediatric large airway diseases: state-of-the-art. Lee, EY., Greenberg, SB., Boiselle, PM.[2016]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Dynamic volumetric computed tomographic assessment of the young paediatric airway: Initial experience of rapid, non-invasive, four-dimensional technique. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ultralow Dose Dynamic Expiratory Computed Tomography for Evaluation of Tracheomalacia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Dynamic computed tomography for evaluation of tracheobronchomalacia in premature infants with bronchopulmonary dysplasia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dynamic airway evaluation with volume CT: initial experience. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Expiratory volumetric MDCT evaluation of air trapping in pediatric patients with and without tracheomalacia. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

Technique, pitfalls, quality, radiation dose and findings of dynamic 4-dimensional computed tomography for airway imaging in infants and children. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Dynamic Volumetric Computed Tomography Angiography is an Effective Method to Evaluate Tracheomalacia in Children. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Helical multi-detector CT scan as a tool for diagnosing tracheomalacia in children. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Multidetector computed tomography of pediatric large airway diseases: state-of-the-art. [2016]