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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01540318
Other study ID # 244545
Secondary ID H34MC19682244545
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date January 2016

Study information

Verified date January 2019
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 925
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Abdominal Ultrasound (FAST examination)
Use of FAST abdominal ultrasound exam

Locations

Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Abdominal CT Scan One week from enrollment
Secondary Total time spent in the Emergency Department 24 hours from enrollment
Secondary Cost effectiveness two months from enrollment
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