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

Recruiting now · Not applicable

Conditions studied: Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury, Abdominal Injury, Abdomen, Acute

In brief

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.

Key facts

Study ID: NCT05910567
Run by: University of California, Davis
People needed: 4346
Starts: 2023-04-17
Expected to finish: 2027-04-30
Last updated by the study team: 2025-12-11

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma
Blunt traumatic event with any of the following (regardless of the mechanism):
Extremity paralysis
Multiple long bone fractures (e.g., tibia and humerus fracture)
History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

You may not qualify if…

The following patients will be excluded from the study:
Age-adjusted low blood pressure (Hemodynamic instability)
Patients will be excluded for prehospital or initial age-adjusted ED low blood pressure. This is because the standard evaluation of these patients involves immediate FAST based on prior work by our group. Low blood pressure is determined based upon the patient's age, and will be defined as a systolic blood pressure less than 70 mm Hg for patients younger than 1 month, less than 80 mm Hg for ages 1 month to 5 years, and less than 90 mm Hg for ages over 5 years.
Penetrating trauma: Patients who are victims of stab or gunshot wounds
Traumatic injury occurring > 24 hours prior to the time of presentation to the ED
Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
Transferred with FAST exam already performed at outside hospital
Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected
Known pregnancy
Known prisoner
Known intra-abdominal injury diagnosed within 30 days prior of this ED visit

Where it is running

University of California, Davis Medical Center — Sacramento, California, United States (enrolling)
University of Colorado, Anschutz Medical Center and Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
Emory University Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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