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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05025150
• Other study ID #: 2019.091EXP
• Status: Recruiting
• Start date: August 11, 2019
• Est. completion date: December 8, 2025

Study information

• Verified date: November 2023
• Source: Sutter Health
• Contact: Samuel Lam, MD, MPH
• Phone: 916 887 1130
• Email: docp2slam[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1020
• Est. completion date: December 8, 2025
• Est. primary completion date: August 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric ALL
• Trauma Chest
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Sutter Medical Center Sacramento	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Sutter Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of POCUS as compared to chest X-ray in detecting injuries		7-10 days
Secondary	Compare the accuracy of POCUS to cross sectional imaging (CT or MRI).		7-10 days
Secondary	Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed).		7-10 days