Skip to main content
Clinical Trials/NCT05025150
NCT05025150
Recruiting
Not Applicable

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

Sutter Health1 site in 1 country1,020 target enrollmentAugust 11, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma Chest
Sponsor
Sutter Health
Enrollment
1020
Locations
1
Primary Endpoint
Accuracy of POCUS as compared to chest X-ray in detecting injuries
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 11, 2019
End Date
December 8, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

HIU FUNG SAMUEL LAM

Attending physician

Sutter Health

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Accuracy of POCUS as compared to chest X-ray in detecting injuries

Time Frame: 7-10 days

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials