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

November 26, 2023 updated by: HIU FUNG SAMUEL LAM, Sutter Health
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1020

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center Sacramento
        • Contact:
          • Samuel Lam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • Suspected penetration injury to neck, chest or abdomen
  • Falls >10 feet or more than 3 times of the child's height
  • Suspected spinal cord injury with neurological deficits
  • Pedestrian or cyclist hit or run over by car at >20mph
  • Motor vehicle collision (MVC) at high speed >50mph or with ejection of occupant
  • MVC with death of another occupant or prolonged extrication time or significant intrusion to passenger compartment.
  • Crash or flip of motorized vehicle with separation of rider from vehicle
  • High voltage electrical injury (>220V)
  • Hanging
  • Submersion injury
  • Trauma mechanism with cardiac arrest or hypotension adjusted for age
  • Explosion injury
  • Treating physician discretion on patients otherwise not meeting any of the above criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of POCUS as compared to chest X-ray in detecting injuries
Time Frame: 7-10 days
7-10 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sutter Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2019

Primary Completion (Estimated)

August 8, 2025

Study Completion (Estimated)

December 8, 2025

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.091EXP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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