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Recruiting NCT05910567

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

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Trial Parameters

Condition Blunt Trauma to Abdomen
Sponsor University of California, Davis
Study Type INTERVENTIONAL
Phase N/A
Enrollment 4,346
Sex ALL
Min Age N/A
Max Age 17 Years
Start Date 2023-04-17
Completion 2027-04-30
Interventions
Focused Assessment with Sonography for Trauma (FAST) ExaminationNo Intervention: Standard of Care - Without the FAST Examination

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Brief 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 Criteria

Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria. Inclusion Criteria: 1. Blunt torso trauma resulting from a significant mechanism of injury: * Motor vehicle collision: greater than 60 mph, ejection, or rollover * Automobile versus pedestrian/bicycle: automobile speed \> 25 mph * Falls greater than 20 feet in height * Crush injury to the torso * Physical assault involving the abdomen 2. Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma 3. Blunt traumatic event with any of the following (regardless of the mechanism): * Extremity paralysis * Multiple long bone fractures (e.g., tibia and humerus fracture) 4. History and physical examination suggestive of blunt torso trauma of

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