- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00424736
the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients
January 18, 2007 updated by: Assaf-Harofeh Medical Center
Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients
Whole body imaging has no role in asymptomatic pediatric trauma patients
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All asymptomatic trauma patients from 0 to 15 years old
Exclusion Criteria:
- Any pediatric trauma patients with clinical indications for CT scan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Igor Jeroukhimov, MD, Assaf-Harofeh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion
January 1, 2008
Study Registration Dates
First Submitted
January 16, 2007
First Submitted That Met QC Criteria
January 18, 2007
First Posted (Estimate)
January 19, 2007
Study Record Updates
Last Update Posted (Estimate)
January 19, 2007
Last Update Submitted That Met QC Criteria
January 18, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- igorjer1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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