A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
University of California, Davis
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.
Description
Trauma is a leading cause of death in children in the US. Abdominal trauma accounts for 30% of all pediatric traumatic deaths, second only to traumatic brain injury. Although CT is the reference standard for diagnosing intra-abdominal injury, it is associated with ionizing radiation, inducing malignancies at an estimated rate of 1 per 500 abdominal CT scans in children \<5 years and 1 per 600 scans in adolescents. Thus, CT use should be limited to those at non-negligible risk of intra-abdominal injury. The Focused Assessment with Sonography for Trauma (FAST) examination has also evolved as a…
Eligibility
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
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…
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 CenterSacramento, California
- University of Colorado, Anschutz Medical Center and Children's Hospital ColoradoAurora, Colorado
- Emory University Children's Healthcare of AtlantaAtlanta, Georgia
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- The Research Institute at Nationwide Children's HospitalColumbus, Ohio
- University of Texas Southwestern Medical CenterDallas, Texas