Clinical trial NCT01540318: Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
Official title: Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Injuries
Keywords: ultrasonography
Abdominal Injuries
Trauma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 925
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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)
* 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

Primary outcomes:
measure: Rate of Abdominal CT Scan
timeFrame: One week from enrollment
Secondary outcomes:
measure: Total time spent in the Emergency Department
timeFrame: 24 hours from enrollment
measure: Cost effectiveness
timeFrame: two months from enrollment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis School of Medicine
name: James F Holmes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.