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Search / Trial NCT05910567

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

Launched by JAMES F. HOLMES, MD, MPH · Jun 13, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Child Wounds And Injuries Blunt Trauma To Abdomen Abdomen Injury Blunt Abdominal Trauma

ClinConnect Summary

This clinical trial is studying how effective a specific ultrasound test called FAST (Focused Assessment with Sonography for Trauma) is in helping doctors evaluate children who have experienced blunt abdominal trauma, like injuries from car accidents or falls. The goal is to see if using this quick and safe bedside ultrasound can reduce the need for more extensive imaging tests like CT scans, which carry higher risks, especially in children who are considered to be at low risk for serious injuries.

To participate in the study, children under 18 who have had significant abdominal trauma within the last 24 hours may be eligible, provided they do not have certain exclusions such as severe low blood pressure or other serious conditions. If enrolled, participants will receive the FAST ultrasound as part of their initial exam, and researchers will analyze how this affects their overall care and the decisions made regarding further imaging. This trial aims to improve the way injured children are assessed and treated, ultimately enhancing their recovery and safety.

Gender

ALL

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

About James F. Holmes, Md, Mph

Dr. James F. Holmes, MD, MPH, is a distinguished clinical trial sponsor with extensive expertise in emergency medicine and public health. With a robust background in conducting and managing clinical research, Dr. Holmes is dedicated to advancing medical knowledge and enhancing patient care through innovative studies. His leadership in clinical trials focuses on developing evidence-based practices and improving health outcomes, particularly in acute care settings. Committed to ethical research practices and collaboration, Dr. Holmes aims to contribute significantly to the scientific community while prioritizing patient safety and well-being.

Locations

Cincinnati, Ohio, United States

Dallas, Texas, United States

Sacramento, California, United States

Columbus, Ohio, United States

Atlanta, Georgia, United States

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

James F Holmes, MD, MPH

Principal Investigator

University of California, Davis

Nathan Kuppermann, MD, MPH

Principal Investigator

University of California, Davis

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported