Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial

Recruiting

• Conditions: Pediatric ALL; Trauma Chest

• Registration Number: NCT05025150
• Lead Sponsor: Sutter Health

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

Not available

Study Timeline

• Study Start: 2019-08-11
• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-08-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-08-08
• Study Completion: 2025-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

• Eligible subjects will be children 0 to 21 years of age presenting to the participating PEDs meeting trauma activation criteria and with suspected thoracic injury.

Exclusion Criteria

• Congenital or acquired cardiopulmonary or osteogenic conditions rendering POCUS ineffective, foreign body/ barrier to lung ultrasound of which removal is contraindicated, subjects under law-enforcement custody, and subjects deemed unsuitable by treating clinicians.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of POCUS as compared to chest X-ray in detecting injuries	7-10 days

Secondary Outcome Measures

Name	Time	Method
Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed).	7-10 days
Compare the accuracy of POCUS to cross sectional imaging (CT or MRI).	7-10 days

Trial Locations

Locations (1)

Sutter Medical Center Sacramento; 🇺🇸 Sacramento, California, United States