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/41388553/Actively Recruiting
Led by University of California, Davis · Updated on 2025-12-11
4346
Participants Needed
6
Research Sites
N/A
Total Duration
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
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
J
James F Holmes, MD, MPH
N
Nathan Kuppermann, MD, MPH
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University of California, Davis
Lead Sponsor
Pediatric Emergency Care Applied Research Network
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | FAST exam (bedside ultrasound) | Standard care without FAST |
|---|---|---|
| What it is | A bedside ultrasound FAST exam performed in addition to usual evaluation | Standard care diagnostic evaluation without the FAST ultrasound |
| Role in trial | Investigational diagnostic test added to evaluation | Control arm reflecting usual evaluation procedures |
| Primary use | To detect intra‑abdominal injury and potentially reduce CT use | To detect intra‑abdominal injury without ultrasound support |
| How it is performed | Bedside ultrasound performed in the emergency department as part of initial evaluation | Evaluation per usual institutional protocols without point‑of‑care ultrasound |
| Evidence status | Evidence is being collected by this RCT to assess effect on CT use and injury detection | Current standard evaluation; CT remains primary imaging modality |
| Important risks | Minimal risk from ultrasound; very low risk non‑ionizing diagnostic procedure | Exposure to ionizing radiation from CT when used |
| Important limitations | Lower sensitivity in children; may miss injuries detected by CT | CT exposes to radiation and may be over‑used in low‑risk children |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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James F Holmes, Daniel J Tancredi, Kenneth M Kelley...
https://pubmed.ncbi.nlm.nih.gov/41388553/University of California, Davis
Lead Sponsor
Pediatric Emergency Care Applied Research Network
Collaborating Sponsor