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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01540318
Enrollment
925
Registered
2012-02-28
Start date
2012-02-29
Completion date
2016-01-31
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Injuries

Keywords

ultrasonography, Abdominal Injuries, Trauma

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.

Interventions

PROCEDUREAbdominal Ultrasound (FAST examination)

Use of FAST abdominal ultrasound exam

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of Abdominal CT ScanOne week from enrollment

Secondary

MeasureTime frame
Total time spent in the Emergency Department24 hours from enrollment
Cost effectivenesstwo months from enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026