the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424736
Recruitment Status : Unknown
Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2007
Last Update Posted : January 19, 2007
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:
Whole body imaging has no role in asymptomatic pediatric trauma patients

Condition or disease Intervention/treatment
Injuries and Wounds Procedure: whole body CT scan

Detailed Description:
Negative physical examination alone has been shown unreliable for excluding intra-abdominal injuries in adult patients with multitrauma. Therefore, the management of patients with a normal clinical examination after blunt trauma is a subject of controversy. Since 1970s, computer tomography (CT) has become the mainstay of evaluating hemodynamically stable trauma patients. It's generally accepted that hemodynamically stable patient with abnormal abdominal examination results require the use of CT as well as patients with depressed level of consciousness. Controversy exists with the awake, clinically evaluable patients with no obvious signs of abdominal and chest trauma. In the last years number of studies express CT role in evaluation of asymptomatic trauma patient with mechanism of injury supporting probability of internal organs injury. Those studies show that in a large number of patients the management was changed according to CT results. The authors recommended liberal use of CT in trauma patient population. All those studies have been performed in adult trauma patients. The purpose of this study is to evaluate the role of whole body imaging in pediatric patients with suspicious mechanism of injury, which are hemodynamically stable and has no obvious signs of chest and abdominal injury. The incidence of injury in these patient population as well as changes in treatment based on results of CT will be examined. Methods The prospective observational study will be performed in Assaf Harofeh Medical Center. All patients up to 15 years old with blunt mechanism of multisystem trauma will be eligible for enrollment to the study. Only patients whose parents singed the inform consent will be enrolled.Inclusion criteria will be based on the mechanism of injury: 1. no visible injury of chest and abdomen2. hemodynamically stable3. normal abdominal examination in neurologically intact patient or unevaluable abdominal examination in patients with depressed level of consciousness. 4. significant mechanism of injury as any of the following a. high speed (more than 55km/hr) motor vehicle accident b. fall of greater than 3 meters c. automobile hitting pedestrian d. assaulted with depressed level of consciousness All patients will undergo CT of the head, chest, abdomen and pelvis as a part of their evaluation. CT scan will be performed in Emergency Department short after patient's admission and clinical evaluation. An abnormal CT will be defined as exhibiting any traumatic abnormality. Patient treatment plan changes will be defined as alteration in management based directly on CT findings.Data regarding patient demographics, mechanism of injury, physical examination findings, Glasgow Coma Score on emergency department admission, Injury Severity Score, radiologic interpretation of chest and pelvic roentgenograms, injuries required operative procedures, laboratory data, CT scan findings, and changes in management plan based on CT findings will be recorded.

Study Type : Observational
Enrollment : 100 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients
Study Start Date : January 2007
Study Completion Date : January 2008

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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All asymptomatic trauma patients from 0 to 15 years old

Exclusion Criteria:

  • Any pediatric trauma patients with clinical indications for CT scan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424736

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Igor Jeroukhimov, MD Assaf-Harofeh Medical Center Identifier: NCT00424736     History of Changes
Other Study ID Numbers: igorjer1
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: January 19, 2007
Last Verified: January 2007

Keywords provided by Assaf-Harofeh Medical Center:
blunt trauma, pediatric patient, imaging, computer tomography

Additional relevant MeSH terms:
Wounds and Injuries