Using Ultrasound to Evaluate Abdominal Injuries in Children After Trauma

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

This study is testing if a quick ultrasound can help doctors check for abdominal injuries in children after trauma, so they can avoid using CT scans that expose them to radiation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4346 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: University of California, Davis (Academic / other)
• Drugs / interventions: radiation
• Locations: 6 sites (Sacramento, California and 5 other locations)
• Trial ID: NCT05910567 on ClinicalTrials.gov

What this trial studies

This research evaluates the effectiveness of the Focused Assessment with Sonography for Trauma (FAST) examination in children with blunt abdominal trauma. The study aims to determine if using FAST can reduce the need for abdominal CT scans, which expose children to harmful radiation. It involves a multicenter, randomized, controlled trial with 3,194 hemodynamically stable children presenting to emergency departments within 24 hours of injury. The FAST examination is a quick, bedside ultrasound that detects fluid in the abdomen, potentially indicating bleeding.

Who should consider this trial

Good fit: Ideal candidates are children under 18 years old with blunt abdominal trauma from significant injury mechanisms.

Not a fit: Patients who do not have blunt abdominal trauma or those who are hemodynamically unstable may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce radiation exposure in children while still effectively diagnosing abdominal injuries.

How similar studies have performed: Other studies have shown promise in using ultrasound for trauma evaluation, but this specific application in children is relatively novel.

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 any mechanism (including mechanisms of injury of less severity than mentioned above)

Exclusion Criteria:

The following patients will be excluded from the study:

1. 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.
2. Penetrating trauma: Patients who are victims of stab or gunshot wounds
3. Traumatic injury occurring \> 24 hours prior to the time of presentation to the ED
4. Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
5. Transferred with FAST exam already performed at outside hospital
6. Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
7. Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected
8. Known pregnancy
9. Known prisoner
10. Known intra-abdominal injury diagnosed within 30 days prior of this ED visit

Where this trial is running

Sacramento, California and 5 other locations

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

Study contacts

• Principal investigator: James F Holmes, MD, MPH — University of California, Davis
• Study coordinator: James F Holmes, MD, MPH

Conditions Blunt Trauma to Abdomen; Wounds and Injuries; Abdomen Injury; Abdominal Injury; Abdomen, Acute; Child; Blunt Abdominal Trauma