ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury (Dual ICP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02911675
Recruitment Status : Not yet recruiting
First Posted : September 22, 2016
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Deborah Stein, University of Maryland

August 24, 2016
September 22, 2016
February 15, 2018
June 2018
June 2020   (Final data collection date for primary outcome measure)
Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping. [ Time Frame: 6 months ]
Investigators want to find a better device that can measure pressure in the head after a traumatic brain without causing an increase in pressure inside of the head.
Same as current
Complete list of historical versions of study NCT02911675 on ClinicalTrials.gov Archive Site
Compare clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF. [ Time Frame: 6 months ]
Compare the current method of clamping the drain with the experimental method to determine if clamping the drain less will provide an accurate measure of pressure inside of the head.
Same as current
Evaluate the impact of the frequency of EVD drain closure on short and long (6 month) term functional outcomes. [ Time Frame: 6 months ]
Assess the impact of the frequency of EVD drain closure on short and long (6 month) term functional outcomes.
Same as current
 
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury

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.

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 EVD/IVC and the IPM/Camino 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 (randbetween(0,1)) 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 IPM/Camino ICP measurements collected.

Experimental (25 patients): Therapeutic CSF drainage as appropriate, with EVD closure and ICP assessment every 12 hours with simultaneous IPM/Camino 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 patient's stay in the Neurotrauma Critical Care Unit will be collected and be stored with the patients study data.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
6 Months
Not Provided
Probability Sample
This is an interventional device study utilizing the EVD/IVC and the IPM/Camino 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 (randbetween(0,1)) 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.
Traumatic Brain Injury
Device: EVD/IVC and the IPM/Camino
This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI.
  • Standard of Care Group
    Study Group 1: Standard EVD/IVC management with therapeutic CSF drainage as appropriate and hourly EVD/IVC ICP measurements per standard of care with simultaneous IPM/Camino ICP measurements collected.
    Intervention: Device: EVD/IVC and the IPM/Camino
  • Experimental Group
    Study Group 2: Therapeutic CSF drainage as appropriate, with EVD/IVC closure and ICP assessment approximately every 12 hours with simultaneous IPM/Camino ICP measurements collected.
    Intervention: Device: EVD/IVC and the IPM/Camino
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Same as current
June 2022
June 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Direct trauma admission to STC by ambulance or helicopter
  • 18 years and older
  • Neurosurgical evaluation indicates placement of a EVD
  • Diagnosis of severe traumatic brain injury (head AIS > 2) and post-resuscitation motor CGS<6

Exclusion Criteria:

  • < 18 years of age
  • Non-survivable brain injury
  • Non-survivable anatomic injury
  • Pregnancy
  • Non-English speaker
  • Prisoner
  • Active duty military
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Not Provided
 
 
NCT02911675
HP-00064113
Yes
Not Provided
Plan to Share IPD: No
Deborah Stein, University of Maryland
University of Maryland
United States Air Force
Not Provided
University of Maryland
February 2018