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the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients
This study is not yet open for participant recruitment.
Study NCT00424736   Information provided by Assaf-Harofeh Medical Center
First Received: January 16, 2007   Last Updated: January 18, 2007   History of Changes

January 16, 2007
January 18, 2007
January 2007
 
 
 
Complete list of historical versions of study NCT00424736 on ClinicalTrials.gov Archive Site
 
 
 
the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients
Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients

Whole body imaging has no role in asymptomatic pediatric trauma patients

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.

Phase 0
Observational
Screening, Longitudinal, Defined Population, Prospective Study
Injuries and Wounds
Procedure: whole body CT scan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
100
January 2008
 

Inclusion Criteria:

  • All asymptomatic trauma patients from 0 to 15 years old

Exclusion Criteria:

  • Any pediatric trauma patients with clinical indications for CT scan
Both
1 Month to 15 Years
No
 
 
 
NCT00424736
 
igorjer1
Assaf-Harofeh Medical Center
 
Principal Investigator: Igor Jeroukhimov, MD Assaf-Harofeh Medical Center
Assaf-Harofeh Medical Center
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP