Utility of Abdominal Ultrasound in the Evaluation of Chil... | NCT01540318

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

NCT01540318

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Jan 16, 2019Actual

Enrollment

925Actual

Phase

Not Applicable

Conditions

Abdominal Injuries

Interventions

Abdominal Ultrasound (FAST examination)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H34MC19682	Other Grant/Funding Number	US Department of Health and Human Services
244545	Other Identifier	UC Davis

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jan 31, 2012

First Submission Date that Met QC Criteria

Feb 27, 2012

First Posted Date

Feb 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2019

Last Update Posted Date

Jan 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

925Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominal Ultrasound	Experimental	Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound.	Procedure: Abdominal Ultrasound (FAST examination)
No Abdominal Ultrasound	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abdominal Ultrasound (FAST examination)	Procedure	Use of FAST abdominal ultrasound exam	Abdominal Ultrasound

Measure	Description	Time Frame
Rate of Abdominal CT Scan		One week from enrollment

Measure	Description	Time Frame
Total time spent in the Emergency Department		24 hours from enrollment
Cost effectiveness		two months from enrollment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
James F Holmes, MD, MPH	UC Davis School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center		Sacramento	California	95817	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28609532	Derived	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.

ID	Term
D000007	Abdominal Injuries
D014947	Wounds and Injuries

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation