RecruitingNot ApplicableNCT05910567

A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma


Sponsor

University of California, Davis

Enrollment

4,346 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.


Eligibility

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Focused Assessment with Sonography for Trauma (FAST) Examination and No Intervention: Standard of Care - Without the FAST Examination for people with abdomen injury, abdomen, acute, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include up to age 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFocused Assessment with Sonography for Trauma (FAST) Examination

A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.

OTHERNo Intervention: Standard of Care - Without the FAST Examination

Participants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.


Locations(6)

University of California, Davis Medical Center

Sacramento, California, United States

University of Colorado, Anschutz Medical Center and Children's Hospital Colorado

Aurora, Colorado, United States

Emory University Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05910567


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