Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage
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|ClinicalTrials.gov Identifier: NCT02172703|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : July 8, 2015
Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure in order to implant the catheter and probes within the brain. The invasiveness of current methods for ICP measurement limits the diagnoses reliability of many neurological conditions in which intracranial hypertension is a treatable adverse event. A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without the need of a surgical intervention.
The aim of this study is to validate a novel non-invasive ICP measurement device by comparing its measurement with the "gold standard" invasive ICP-measurement by intracranial probe. The device used in this study has been been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.
The non-invasive ICP measurement method will be assessed prospectively using repeatable simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on patients presenting with TBI and SAH. The device method is based on two-depth transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe externally applied by the device. Two-depth TCD device is used as an accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in the intracranial and extracranial segments of OA are identical. The device has the same ultrasound transmission parameters as existing TCD devices and meets all patient safety criteria.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury (TBI) Subarachnoid Hemorrhage (SAH)||Device: Non-invasive ICP measurement device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Non-invasive ICP measurement
non-invasive ICP measurement with NON-INVASIVE ICP ABSOLUTE VALUE METER (carried out simultainusly with standard invasive ICP measurement catheter and probes)
Device: Non-invasive ICP measurement device
The non-invasive ICP measurement device used in this study has been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.
The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA).
- Simultaneously measured non-invasive and invasive ICP values in mmHg (millimeters of mercury) [ Time Frame: Max. 3 times/day - approx. 24hours to 30 days after addmission (as long as patient is monitored with invasive ICPprobe) ]
Physiological parameters of TBI or SAH patients of primary interest are simultaneously measured paired non-invasive and invasive ICP values.
New measurement is only initiated if ICP changes for more than 4mmHg in comparison to proceeding measurement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172703
|Kantonsspital Aarau, Department of Neurosurgery|
|Aarau, Aargau, Switzerland, 5001|
|Principal Investigator:||Javier Fandino, M.D.||Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland|