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

Last updated: November 26, 2023
Sponsor: Sutter Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05025150
2019.091EXP
  • Ages < 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible subjects will be children 0 to 21 years of age presenting to theparticipating PEDs meeting trauma activation criteria and with suspected thoracicinjury.

Exclusion

Exclusion Criteria:

  • Congenital or acquired cardiopulmonary or osteogenic conditions rendering POCUSineffective, foreign body/ barrier to lung ultrasound of which removal iscontraindicated, subjects under law-enforcement custody, and subjects deemedunsuitable by treating clinicians.

Study Design

Total Participants: 1020
Study Start date:
August 11, 2019
Estimated Completion Date:
December 08, 2025

Connect with a study center

  • Sutter Medical Center Sacramento

    Sacramento, California 95816
    United States

    Active - Recruiting

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