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Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by University of California, Davis.
Recruitment status was:  Enrolling by invitation
Information provided by (Responsible Party):
University of California, Davis Identifier:
First received: January 31, 2012
Last updated: February 27, 2012
Last verified: February 2012

The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:

  1. rate of abdominal CT scanning
  2. time to emergency department disposition
  3. the rate of missed/delayed diagnosis of intra-abdominal injury
  4. the costs.

Condition Intervention
Abdominal Injuries
Procedure: Abdominal Ultrasound (FAST examination)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Rate of Abdominal CT Scan [ Time Frame: One week from enrollment ]

Secondary Outcome Measures:
  • Total time spent in the Emergency Department [ Time Frame: 24 hours from enrollment ]
  • Cost effectiveness [ Time Frame: two months from enrollment ]

Estimated Enrollment: 916
Study Start Date: February 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abdominal Ultrasound
Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound.
Procedure: Abdominal Ultrasound (FAST examination)
Use of FAST abdominal ultrasound exam
Other Name: Focused Assesment with Sonography for Trauma
No Intervention: No Abdominal Ultrasound


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 score < 15 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 intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

Exclusion Criteria:

  • No concern for inter-abdominal injury or no planned evaluation for possible IAI
  • Prehospital or ED age adjusted Hypotension
  • Prehospital or initial ED GCS score ≤ 8
  • Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
  • Penetrating trauma: stab or gunshot wounds
  • Traumatic injury occurring > 24 hours prior to the time of presentation to the ED
  • Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
  • Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01540318

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Principal Investigator: James F Holmes, MD, MPH UC Davis School of Medicine
  More Information

Responsible Party: University of California, Davis Identifier: NCT01540318     History of Changes
Other Study ID Numbers: 244545-4
H34MC19682 ( Other Grant/Funding Number: US Department of Health and Human Services )
Study First Received: January 31, 2012
Last Updated: February 27, 2012

Keywords provided by University of California, Davis:
Abdominal Injuries

Additional relevant MeSH terms:
Abdominal Injuries
Wounds, Nonpenetrating
Wounds and Injuries processed this record on April 25, 2017