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Clinical Trials/NCT01540318
NCT01540318
Completed
Not Applicable

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

University of California, Davis1 site in 1 country925 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Injuries
Sponsor
University of California, Davis
Enrollment
925
Locations
1
Primary Endpoint
Rate of Abdominal CT Scan
Status
Completed
Last Updated
7 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
February 2012
End Date
January 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

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

Outcomes

Primary Outcomes

Rate of Abdominal CT Scan

Time Frame: One week from enrollment

Secondary Outcomes

  • Total time spent in the Emergency Department(24 hours from enrollment)
  • Cost effectiveness(two months from enrollment)

Study Sites (1)

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