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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01540318
First received: January 31, 2012
Last updated: June 19, 2017
Last verified: June 2017
January 31, 2012
June 19, 2017
February 2012
February 2016   (Final data collection date for primary outcome measure)
Rate of Abdominal CT Scan [ Time Frame: One week from enrollment ]
Same as current
Complete list of historical versions of study NCT01540318 on ClinicalTrials.gov Archive Site
  • Total time spent in the Emergency Department [ Time Frame: 24 hours from enrollment ]
  • Cost effectiveness [ Time Frame: two months from enrollment ]
Same as current
Not Provided
Not Provided
 
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Diagnostic
Abdominal Injuries
Procedure: Abdominal Ultrasound (FAST examination)
Use of FAST abdominal ultrasound exam
Other Name: Focused Assesment with Sonography for Trauma
  • 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.
    Intervention: Procedure: Abdominal Ultrasound (FAST examination)
  • No Intervention: No Abdominal Ultrasound
Holmes JF, Kelley KM, Wootton-Gorges SL, Utter GH, Abramson LP, Rose JS, Tancredi DJ, Kuppermann N. Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2290-2296. doi: 10.1001/jama.2017.6322.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
925
December 2017
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01540318
244545
H34MC19682 ( Other Grant/Funding Number: US Department of Health and Human Services )
244545 ( Other Identifier: UC Davis )
Yes
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: James F Holmes, MD, MPH UC Davis School of Medicine
University of California, Davis
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP