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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540318
Recruitment Status : Active, not recruiting
First Posted : February 28, 2012
Last Update Posted : February 21, 2018
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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 or disease Intervention/treatment
Abdominal Injuries Procedure: Abdominal Ultrasound (FAST examination)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 925 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
Study Start Date : February 2012
Primary Completion Date : February 2016
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of California, Davis Identifier: NCT01540318     History of Changes
Other Study ID Numbers: 244545
H34MC19682 ( Other Grant/Funding Number: US Department of Health and Human Services )
244545 ( Other Identifier: UC Davis )
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by University of California, Davis:
Abdominal Injuries

Additional relevant MeSH terms:
Abdominal Injuries
Wounds, Nonpenetrating
Wounds and Injuries