Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT00424736 |
| Other study ID # |
igorjer1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 0
|
| First received |
January 16, 2007 |
| Last updated |
January 18, 2007 |
| Start date |
January 2007 |
| Est. completion date |
January 2008 |
Study information
| Verified date |
January 2007 |
| Source |
Assaf-Harofeh Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Israel: The Israel National Institute for Health Policy Research and Health Services Research |
| Study type |
Observational
|
Clinical Trial Summary
Whole body imaging has no role in asymptomatic pediatric trauma patients
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.
