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

Not Applicable

Completed

• Conditions: Abdominal Injuries
• Interventions: Procedure: Abdominal Ultrasound (FAST examination)

• Registration Number: NCT01540318
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 925

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal Ultrasound	Abdominal Ultrasound (FAST examination)	Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound.

Primary Outcome Measures

Name	Time	Method
Rate of Abdominal CT Scan	One week from enrollment

Secondary Outcome Measures

Name	Time	Method
Total time spent in the Emergency Department	24 hours from enrollment
Cost effectiveness	two months from enrollment

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States