Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02911675
Status:
WITHDRAWN
Last Update Posted:
2022-01-18
First Post:
2016-08-24
Brief Title:
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the lack of approval from the Air Force IRB patient enrollment was never initiated Thus no clinical results could be examined or can be reported
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dual ICP
Brief Summary:
Traumatic brain injury TBI is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties While primary brain injury cannot be reversed the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part of the downstream effects of the primary damage to the brain Many secondary injury mechanisms are manifested clinically as elevated intracranial pressure ICP and cerebral perfusion pressure CCP This level and duration of elevated ICP is strongly associated with poor long term patient outcome
Currently there are two invasive techniques that are used at our facility for monitoring ICP and CPP The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor IPM also known as a camino into the brain tissue that measures and displays ICP continuously The second method requires placement of an extracranial ventricular drain EVD which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid CFS to reduce pressure within the skull when it is open
While clinical practices vary greatly across institutions current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis However in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline Due to the strong association between poor patient outcome and elevated ICP this finding is alarming These findings have important implications for procedures to not only treat elevated ICP but also prevent potentially harmful intermittent elevations in ICP Therefore this study seeks to prospectively investigate the association between EVD clamping and elevated ICP
Specifically this study has 2 main objectives
1 Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping
2 Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF
Currently there are two invasive techniques that are used at our facility for monitoring ICP and CPP The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor IPM also known as a camino into the brain tissue that measures and displays ICP continuously The second method requires placement of an extracranial ventricular drain EVD which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid CFS to reduce pressure within the skull when it is open
While clinical practices vary greatly across institutions current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis However in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline Due to the strong association between poor patient outcome and elevated ICP this finding is alarming These findings have important implications for procedures to not only treat elevated ICP but also prevent potentially harmful intermittent elevations in ICP Therefore this study seeks to prospectively investigate the association between EVD clamping and elevated ICP
Specifically this study has 2 main objectives
1 Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping
2 Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF
Detailed Description:
Investigators plan a single-center 36 month prospective observational study of 50 patients presenting with moderate to severe traumatic brain injury TBI at R Adams Cowley Shock Trauma Center who require intracranial pressure monitoring This is an interventional device study utilizing the EVDIVC and the IPMCamino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI Enrolled patients will be randomized to one of two study groups listed below following the consent process Once a potential participant has consented to the study we will use the excel random number generator function randbetween01 to generate random numbers between 0 and 1 for each participant If 0 is generated participants will be placed in Group 1 Hourly EVD closures and if 1 is generated participants will be placed in Group 2 EVD closure every 12 hours There is no placebo or control group
Standard of Care 25 patients Standard EVD management with therapeutic drainage as appropriate and hourly EVD ICP measurements with simultaneous IPMCamino ICP measurements collected
Experimental 25 patients Therapeutic CSF drainage as appropriate with EVD closure and ICP assessment every 12 hours with simultaneous IPMCamino ICP measurements collected
Data will be collected on age mechanism of injury time interval between injury and MRI past medical history admission hemodynamics admission component GCS post-resuscitation component GCS injury severity score abbreviated injury score for head injury blunt carotid or vertebral artery injury and therapeutic interventions Continuous vital signs streams will be collected
In addition if available video surveillance from the patients stay in the Neurotrauma Critical Care Unit will be collected and be stored with the patients study data
Standard of Care 25 patients Standard EVD management with therapeutic drainage as appropriate and hourly EVD ICP measurements with simultaneous IPMCamino ICP measurements collected
Experimental 25 patients Therapeutic CSF drainage as appropriate with EVD closure and ICP assessment every 12 hours with simultaneous IPMCamino ICP measurements collected
Data will be collected on age mechanism of injury time interval between injury and MRI past medical history admission hemodynamics admission component GCS post-resuscitation component GCS injury severity score abbreviated injury score for head injury blunt carotid or vertebral artery injury and therapeutic interventions Continuous vital signs streams will be collected
In addition if available video surveillance from the patients stay in the Neurotrauma Critical Care Unit will be collected and be stored with the patients study data
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