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

NCT05910567 | Recruiting DMC

• 2 other identifiers: 1943798R01HD102571
• Study Type: interventional
• Target: 4,346
• Locations: 1 country
• Sites: 6

Brief 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

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

Keywords

Child; Wounds and Injuries; Blunt Trauma to Abdomen; Abdomen Injury; Blunt Abdominal Trauma

Outcome Measures

Primary Outcomes (3)

• Rate of abdominal CT scanning

  The primary outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).

  For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours)

• Rate of delayed or missed or delayed intra-abdominal injuries

  The rate of missed or delayed intra-abdominal injuries (IAI) will be identified and reported for any cases with a delay in diagnosis (i.e., patients diagnosed with IAI in the hospital after ED disposition) or missed IAI (IAI diagnosed after discharge from the ED/hospital).

  In hospitalized participants, IAI collection will be captured from the time of assignment until discharge (up to 30 days). For participants discharged from the ED IAI collection will be captured from the time of assignment until 7 days after ED discharge

• Identifying variables associated with obtaining abdominal CT scans in very low risk patients with normal FAST examinations

  This primary outcome will be a binary indicator (yes/no) for whether the patient with a normal FAST examination who is thought by the clinician to have less than a 1% risk of intra-abdominal injury nonetheless undergoes abdominal CT (outcome of interest).

  The binary indicator assessment of yes/no will occur upon discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours

Secondary Outcomes (5)

• Emergency Department (ED) length of stay

  ED length of stay will be calculated in minutes from the time of ED arrival until the time of ED discharge or the time from ED arrival until the time of hospital admission assessed up to 7 days.

• Rate of Hospitalization

  The assessment of the categorical variable yes/no will occur upon the participants discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours

• Physician suspicion of intra-abdominal injury

  All physician suspicion assessments will occur up to 24 hours after a participants ED presentation

• Rate of abdominal CT scanning in children 0 to 3 years of age.

  For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours).

• Laparotomy (surgery to the abdomen) rate

  For the first seven days after the time of injury.

Study Arms (2)

Focused Assessment with Sonography for Trauma (FAST) Examination Arm

OTHER

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.

Diagnostic Test: Focused Assessment with Sonography for Trauma (FAST) Examination

No Intervention - Standard of Care - Without the FAST Examination

OTHER

Institution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma.

Other: No Intervention: Standard of Care - Without the FAST Examination

Interventions

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.

No Intervention - Standard of Care - Without the FAST Examination

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.

Also known as: Abdominal Ultrasound

Focused Assessment with Sonography for Trauma (FAST) Examination Arm

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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
• Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma
• Blunt traumatic event with any of the following (regardless of the mechanism):
• Extremity paralysis
• Multiple long bone fractures (e.g., tibia and humerus fracture)
• History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
• The following patients will be excluded from the study:
• 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.
• Penetrating trauma: Patients who are victims of stab or gunshot wounds

Sponsors & Collaborators

• University of California, Davis: lead
• Pediatric Emergency Care Applied Research Network: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (6)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

University of Colorado, Anschutz Medical Center and Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Emory University Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (1)

• Holmes JF, Tancredi DJ, Kelley KM, Griffiths M, Gold DL, Lam SHF, Stone B, Brenkert T, Andrade AN, Hanson E, Gwal K, Kornblith A, Hirose S, Utter GH, Kuppermann N. Abdominal ultrasound (FAST) in hemodynamically stable children with blunt abdominal trauma: study protocol for a randomized controlled trial. Trials. 2025 Dec 12;26(1):564. doi: 10.1186/s13063-025-09137-6.

  PMID: 41388553 DERIVED

Related Links

• Pediatric Emergency Care Applied Research Network

MeSH Terms

Conditions

Wounds and Injuries; Abdominal Injuries; Abdomen, Acute

Interventions

Ultrasonography; Physical Examination

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• James F Holmes, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Nathan Kuppermann, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James F Holmes, MD, MPH

CONTACT

916-734-1533; jfholmes@ucdavis.edu

Nathan Kuppermann, MD, MPH

CONTACT

916-734-1535; nkuppermann@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients meeting enrollment criteria will be randomized to the FAST examination arm or to a standard of care/non-FAST examination arm using computer randomized order of enrollment. Randomization will be stratified by site and age group. Age groups will consist of participants 0 to their 3rd birthday and participants 3 years of age up to their 18th birthday. A minimum of 794 participants will be enrolled in the 0 to younger than 3 years of age group. To ensure concealment, opaque envelopes will be prepared at each study site using the randomization scheme provided by the lead institution. These envelopes will be readily available in the ED, provide the investigator with the randomized assignment, and contain the appropriate data collection form.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 18, 2023
• Study Start: April 17, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)