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OpenTrials
Completed

NCT Number: NCT01540318

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.

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Key information

Conditions

Abdominal Injuries Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal Ultrasound (FAST examination)

Procedure

Use of FAST abdominal ultrasound exam

Other names: Focused Assesment with Sonography for Trauma

Primary outcomes

  1. Rate of Abdominal CT Scan

    Time frame: One week from enrollment

Secondary outcomes

  1. Total time spent in the Emergency Department

    Time frame: 24 hours from enrollment

  2. Cost effectiveness

    Time frame: two months from enrollment

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 28, 2012
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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