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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05025150
Enrollment
1020
Registered
2021-08-27
Start date
2019-08-11
Completion date
2025-12-08
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric ALL, Trauma Chest

Keywords

Ultrasonography

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.

Interventions

None listed

Sponsors

Sutter Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Accuracy of POCUS as compared to chest X-ray in detecting injuries7-10 days

Secondary

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

Countries

United States

Contacts

Primary ContactSamuel Lam, MD, MPH
docp2slam@gmail.com916 887 1130

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026