Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424736
Status:
UNKNOWN
Last Update Posted:
2007-01-19
First Post:
2007-01-16
Brief Title:
the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Whole body imaging has no role in asymptomatic pediatric trauma patients
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 Its 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 enrolledInclusion 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 55kmhr 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 patients 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 findingsData 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None