the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00424736
First received: January 16, 2007
Last updated: January 18, 2007
Last verified: January 2007
  Purpose

Whole body imaging has no role in asymptomatic pediatric trauma patients


Condition Intervention Phase
Injuries and Wounds
Procedure: whole body CT scan
Phase 0

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   1 Month to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All asymptomatic trauma patients from 0 to 15 years old

Exclusion Criteria:

  • Any pediatric trauma patients with clinical indications for CT scan
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424736

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Igor Jeroukhimov, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00424736     History of Changes
Other Study ID Numbers: igorjer1
Study First Received: January 16, 2007
Last Updated: January 18, 2007
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014