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

Abdominal Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540318
• Other study ID #: 244545
• Secondary ID: H34MC19682244545
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Injuries
• Wounds, Nonpenetrating

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