search
Back to results

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

Primary Purpose

Abdominal Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abdominal Ultrasound (FAST examination)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Injuries focused on measuring ultrasonography, Abdominal Injuries, Trauma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Abdominal Ultrasound

No Abdominal Ultrasound

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of Abdominal CT Scan

Secondary Outcome Measures

Total time spent in the Emergency Department
Cost effectiveness

Full Information

First Posted
January 31, 2012
Last Updated
January 15, 2019
Sponsor
University of California, Davis
search

1. Study Identification

Unique Protocol Identification Number
NCT01540318
Brief Title
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
Official Title
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: rate of abdominal CT scanning time to emergency department disposition the rate of missed/delayed diagnosis of intra-abdominal injury the costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Injuries
Keywords
ultrasonography, Abdominal Injuries, Trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
925 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominal Ultrasound
Arm Type
Experimental
Arm Description
Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound.
Arm Title
No Abdominal Ultrasound
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Abdominal Ultrasound (FAST examination)
Other Intervention Name(s)
Focused Assesment with Sonography for Trauma
Intervention Description
Use of FAST abdominal ultrasound exam
Primary Outcome Measure Information:
Title
Rate of Abdominal CT Scan
Time Frame
One week from enrollment
Secondary Outcome Measure Information:
Title
Total time spent in the Emergency Department
Time Frame
24 hours from enrollment
Title
Cost effectiveness
Time Frame
two months from enrollment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F Holmes, MD, MPH
Organizational Affiliation
UC Davis School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28609532
Citation
Holmes JF, Kelley KM, Wootton-Gorges SL, Utter GH, Abramson LP, Rose JS, Tancredi DJ, Kuppermann N. Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2290-2296. doi: 10.1001/jama.2017.6322.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs