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

NCT05025150 | Unknown

• 1 other identifier: 2019.091EXP
• Study Type: observational
• Target: 1,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Chest; Pediatric ALL

Keywords

Ultrasonography

Outcome Measures

Primary Outcomes (1)

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

  7-10 days

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Thoracic Injuries; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Samuel Lam, MD, MPH

CONTACT

916 887 1130; docp2slam@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 27, 2021
• Study Start: August 11, 2019
• Primary Completion: August 8, 2025
• Study Completion: December 8, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)