Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00703495
Status:
COMPLETED
Last Update Posted:
2009-04-06
First Post:
2008-06-19
Brief Title:
Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury TBI
Sponsor:
Hospitales Universitarios Virgen del Rocío
Organization:
Hospitales Universitarios Virgen del Rocío
Study Overview
Official Title:
Validation of Non- Invasive Regional Transcranial Oxygen Saturation rSO2 by Comparison With Invasive Brain Tissue Oxygenation PbtO 2 Measurement in Patients With Severe Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
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:
The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation rSO2 brain tissue oxygen pressure PbtO2 and cerebral perfusion pressure CPP in patients with severe traumatic brain injury TBI
Detailed Description:
Experience with rsO2 assessed by near infrared spectroscopy NIRS in patients with severe TBI is lacking Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value Continuous time-domain analysis comparing rSO2 PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI
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