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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Focused Assessment with Sonography for Trauma (FAST) Examination — DIAGNOSTIC_TEST
  A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.
• No Intervention: Standard of Care - Without the FAST Examination — OTHER
  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.

Study Details

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.

Key Dates

Start date

Apr 17, 2023

Status verified

Dec 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

4,346 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Other: Focused Assessment with Sonography for Trauma (FAST) Examination Arm
  Patients in this arm will under the FAST examination (abdominal ultrasound) for diagnostic purposes to detect the presence of blood in injured patients with blunt abdominal trauma.
• Other: No Intervention - Standard of Care - Without the FAST Examination
  Institution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma.

Primary Outcome Measure

Rate of abdominal CT scanning [ Time Frame: For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours) ]

Central Contacts

• James F Holmes, MD, MPH
  916-734-1533
  [email protected]
• Nathan Kuppermann, MD, MPH
  916-734-1535
  [email protected]

Locations (6)

Find similar trials in Sacramento, CA

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