Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-02 @ 7:41 AM
Study NCT ID:
NCT05025150
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2021-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
Sponsor:
Sutter Health
Organization:
Study Overview
Official Title:
Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the proposed study is to investigate the diagnostic accuracy of ED POCUS in pediatric traumatic thoracic injuries including traumatic pneumothorax, hemothorax, lung contusion, rib fractures, and pulmonary edema (from submersion injury). This will be a prospective, multicenter, observational study of children 0-21 years of age presenting to the participating pediatric emergency departments for suspected traumatic thoracic injury. Results of POCUS will be compared to that of chest X-ray, final clinical diagnosis, computed tomography (CT) or magnetic resonance imaging (MRI). Study hypotheses are that POCUS is highly accurate (90-95%) when compared to chest X-ray, and moderately accurate (\~80%) when compared to CT or MRI in diagnosing these conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: