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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1020 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-11

Study Completion Date

2025-12-08

Brief Summary

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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

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Conditions

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Trauma Chest Pediatric ALL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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HIU FUNG SAMUEL LAM

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Samuel Lam, MD, MPH

Role: CONTACT

[email protected]

916 887 1130

Facility Contacts

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Samuel Lam, MD

Role: primary

Other Identifiers

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2019.091EXP

Identifier Type: -

Identifier Source: org_study_id