| Registry | NCT06028646 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, diagnostic |
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| Enrollment | 14 (Actual) |
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| Sponsor | NYU Langone Health (Other) |
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| Conditions | Tracheomalacia |
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| Interventions | Dynamic Airway CT scan (DA-CT) (Device) |
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| Dates | start 2023-08-10, primary completion 2024-06-17, completion 2024-06-17, first posted 2023-09-08, last updated 2026-10-20 |
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| Locations | 2 sites in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Tracheomalacia All trials of Dynamic Airway CT scan (DA-CT)
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Dynamic Airway CT scan (DA-CT) | Experimental | Device: Dynamic Airway CT scan (DA-CT) | All participants will have a DA-CT scan after flexible bronchoscopy has been performed. |
- Dynamic Airway CT scan (DA-CT) (Device): Patient will be asked to perform movements during the scan.
+Outcome measures
Primary outcomes
- Number of Participants With Tracheomalacia Identified by DA-CT [Day 0 (Imaging Visit)]: Presence of tracheomalacia identified by the DA-CT procedure (binary).
Secondary outcomes
- Image Noise in Tracheal Air Column Region of Interest (ROI) [Day 0 (Imaging Visit)]: Image noise was measured from CT attenuation values in the tracheal air-column region-of-interest. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
- Image Noise in Largest Imaged Mediastinal Artery ROI [Day 0 (Imaging Visit)]: Image noise was measured from CT attenuation values in the largest imaged mediastinal artery ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
- Image Noise in Entire Two-Dimensional Right Lung Measurement ROI [Day 0 (Imaging Visit)]: Image noise was measured from CT attenuation values in the entire 2-D right lung measurement ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
- Image Noise in Subcutaneous Fat ROI [Day 0 (Imaging Visit)]: Image noise was measured from CT attenuation values in the subcutaneous fat ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
- Image Noise in Ambient Air ROI [Day 0 (Imaging Visit)]: Image noise was measured from CT attenuation values in the ambient air ROI. Attenuation values within the ROI were recorded in Hounsfield Units (HU), a standardized CT scale in which water is assigned a value of 0 HU and air is assigned a value of approximately -1,000 HU; denser materials have higher HU values. Image noise was calculated as the standard deviation (SD) of those HU values. Higher image noise values indicate greater image noise. Results are summarized using the median and interquartile range (IQR).
- Radiation Exposure of DA-CT Scanners [Day 0 (Imaging Visit)]: Dose length product (DLP), CT radiation dose metric representing the total energy delivered, measured in mGy·cm (milligray-centimeters) used to monitor overall radiation risk and establish reference levels
- Radiation Exposure of DA-CT Scanners [Day 0 (Imaging Visit)]: Size specific dose estimate (SSDE), computed tomography (CT) radiation dose metric (measured in mGy) that provides a more accurate estimation of the radiation absorbed by a patient compared to the traditional Volume CT Dose Index
+Eligibility
Sex: All, ages: 0 Years to 18 Years
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
+Posted results
Participant flow
| Milestone | Dynamic Airway CT Scan (DA-CT) |
|---|
| Started | 14 |
| Completed | 11 |
| Not completed | 3 |
Outcome results
- Number of Participants With Tracheomalacia Identified by DA-CT (Primary), Count of participants, Participants: Dynamic Airway CT Scan (DA-CT) 0
- Image Noise in Tracheal Air Column Region of Interest (ROI) (Secondary), Median, Hounsfield Units (HU): Dynamic Airway CT Scan (DA-CT) 86 (83.4 to 91)
- Image Noise in Largest Imaged Mediastinal Artery ROI (Secondary), Median, Hounsfield Units (HU): Dynamic Airway CT Scan (DA-CT) 88 (81 to 91)
- Image Noise in Entire Two-Dimensional Right Lung Measurement ROI (Secondary), Median, Hounsfield Units (HU): Dynamic Airway CT Scan (DA-CT) 98 (91 to 112)
- Image Noise in Subcutaneous Fat ROI (Secondary), Median, Hounsfield Units (HU): Dynamic Airway CT Scan (DA-CT) 91 (85 to 96)
- Image Noise in Ambient Air ROI (Secondary), Median, Hounsfield Units (HU): Dynamic Airway CT Scan (DA-CT) 79 (76 to 87)
- Radiation Exposure of DA-CT Scanners (Secondary), Median, mGy·cm: Dynamic Airway CT Scan (DA-CT) 4.1 (1.9 to 8.4)
- Radiation Exposure of DA-CT Scanners (Secondary), Median, mGy: Dynamic Airway CT Scan (DA-CT) 1.3 (0.7 to 2.6)
Adverse events
Time frame: 1 Day (day of appointment)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Dynamic Airway CT Scan (DA-CT) | 0/14 (0.0%) | 0/14 (0.0%) | 0/14 (0.0%) |
+Locations (2)
| Facility | City | Country | Status |
|---|
| Fink Children's Ambulatory Center/Hassenfeld Children's Center | New York, New York | United States | |
| Tisch Hospital | New York, New York | United States | |
+Study documents
+Investigators