Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02754063
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2016-04-15
Brief Title:
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2022-05
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:
OXY-TC
Brief Summary:
Post-traumatic brain hypoxiaischemia develops hours after traumatic brain injury TBI and its intensity is directly related to the neurological outcome The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit ICU
The calculation of cerebral perfusion pressure CPP with CPP mean arterial pressure MAP - intracranial pressure ICP has become the most used estimator of cerebral blow flow To prevent ischemia due to elevated ICP current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg However episodes of brain hypoxiaischemia as assessed with brain tissue oxygen pressure PbtO2 measurements might occur despite optimization of CPP and ICP and have been independently associated with poorer patient outcome PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICPCPP-directed therapy in cohort studies of severely head-injured patients On the basis of these findings it is hypothesized that an early optimization of brain oxygenation together with keeping ICP and CPP within recommended values could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome
The calculation of cerebral perfusion pressure CPP with CPP mean arterial pressure MAP - intracranial pressure ICP has become the most used estimator of cerebral blow flow To prevent ischemia due to elevated ICP current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg However episodes of brain hypoxiaischemia as assessed with brain tissue oxygen pressure PbtO2 measurements might occur despite optimization of CPP and ICP and have been independently associated with poorer patient outcome PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICPCPP-directed therapy in cohort studies of severely head-injured patients On the basis of these findings it is hypothesized that an early optimization of brain oxygenation together with keeping ICP and CPP within recommended values could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome
Detailed Description:
None
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