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

Summary

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.

Conditions

• Blunt Trauma to Abdomen
• Wounds and Injuries
• Abdomen Injury
• Abdominal Injury
• Abdomen, Acute

Interventions

DIAGNOSTIC_TEST

Focused Assessment with Sonography for Trauma (FAST) Examination

A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.

OTHER

No Intervention: Standard of Care - Without the FAST Examination

Participants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.

Sponsors & Collaborators

• Pediatric Emergency Care Applied Research Network

  collaborator NETWORK

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of California, Davis

  lead OTHER

Principal Investigators

• James F Holmes, MD, MPH · University of California, Davis

• Nathan Kuppermann, MD, MPH · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• United States

Study Locations