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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

925 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Abdominal Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Abdominal Ultrasound

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

Group Type EXPERIMENTAL

Abdominal Ultrasound (FAST examination)

Intervention Type PROCEDURE

Use of FAST abdominal ultrasound exam

No Abdominal Ultrasound

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Abdominal Ultrasound (FAST examination)

Use of FAST abdominal ultrasound exam

Intervention Type PROCEDURE

Other Intervention Names

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Focused Assesment with Sonography for Trauma

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No