Abdominal ultrasound (FAST) in hemodynamically stable children with blunt abdominal trauma: study protocol for a randomized controlled trial.
James F Holmes, Daniel J Tancredi, Kenneth M Kelley...
https://pubmed.ncbi.nlm.nih.gov/41388553Actively Recruiting
Phase Not Applicable
Age: 0 - 17Years
All Genders
ID05910567
A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Led by University of California, Davis · Updated on 2025-12-11
4346
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
P
Pediatric Emergency Care Applied Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Trauma is a leading cause of death in children in the US, with abdominal trauma accounting for 30% of pediatric traumatic deaths, second only to brain injury. This research evaluates the use of the Focused Assessment with Sonography for Trauma (FAST) examination, a bedside abdominal ultrasound, to determine if it can safely reduce abdominal CT scans in hemodynamically stable children with blunt abdominal trauma. The study aims to improve care quality and reduce morbidity and mortality by identifying appropriate evaluation strategies for injured children. The trial is a multicenter, randomized, controlled study involving 3,194 children under 18 years presenting within 24 hours of blunt abdominal trauma. Participants are assigned to either the FAST examination arm, where a bedside ultrasound is performed to detect blood in the abdomen, or to the standard care arm without FAST. The FAST exam is quick, radiation-free, and performed by emergency or trauma physicians. The study compares CT scan rates and tracks delayed or missed diagnoses of intra-abdominal injuries over up to 30 days. Throughout the emergency department stay and initial hospitalization (up to 24 hours), participants undergo assessments including FAST or standard evaluation, CT scan monitoring, and tracking of injuries for up to 30 days if hospitalized. Outcomes measured include CT scan frequency, missed injuries, emergency department length of stay, hospitalization rates, physician suspicion of injury, and surgery rates. The study also examines factors influencing CT use in low-risk patients after a negative FAST exam, aiming to optimize diagnostic care in pediatric trauma.
CONDITIONS
Brief Title
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Who Can Participate
Age: 0 - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting within 24 hours of injury
- Blunt torso trauma from significant injury mechanisms such as high-speed motor vehicle collisions, automobile versus pedestrian/bicycle injuries at speeds over 25 mph, falls greater than 20 feet, crush injuries to the torso, or physical assaults involving the abdomen
- Decreased level of consciousness with Glasgow Coma Scale score 9-14 or age-appropriate behavior changes related to blunt torso trauma
- Blunt trauma with signs such as extremity paralysis or multiple long bone fractures
- History and physical exam suggestive of blunt torso trauma regardless of injury mechanism severity
You will not qualify if you...
- Age-adjusted low blood pressure indicating hemodynamic instability
- Penetrating trauma such as stab or gunshot wounds
- Injury occurring more than 24 hours before emergency department presentation
- Transfer from outside hospital with prior abdominal CT, diagnostic peritoneal lavage, or laparotomy
- Transfer from outside hospital with FAST exam already performed
- Known diseases causing intraperitoneal fluid like liver failure or ventriculoperitoneal shunts
- Initial Glasgow Coma Scale score of 8 or less
- Known pregnancy
- Known prisoner status
- Known intra-abdominal injury diagnosed within 30 days before this emergency visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 24 hours
Participants undergo evaluation for blunt abdominal trauma using either the Focused Assessment with Sonography for Trauma (FAST) examination or standard care without FAST to detect intra-abdominal injury.
1 visit during Emergency Department stay and initial hospitalization
Long-term Monitoring
Duration - Up to 30 days for hospitalized participants or 7 days after ED discharge
Participants are monitored for missed or delayed intra-abdominal injuries after initial evaluation, depending on hospitalization status or emergency department discharge.
Follow-up assessments depending on hospitalization or discharge status
Trial Site Locations
Total: 6 locations
1
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
University of Colorado, Anschutz Medical Center and Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Emory University Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
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Research Team
J
James F Holmes, MD, MPH
N
Nathan Kuppermann, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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