Traumatic Brain Injury Clinical Trial
Official title:
Open Study on the Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
Primary objective of this study is to assess the accuracy and precision of intracranial
pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid
hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive,
measurement.
Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement
in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous,
non-invasive measurement and standard, invasive,measurement
Currently, ICP (Intracranial Pressure) can be measured only using invasive techniques. In a
previous (pilot study) a non-invasive technique for measurement of ICP was investigated
(based on simultaneously measuring of ophthalmic artery (OA) blood flow parameters in the
intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transcranial
Doppler (TCD)). Based on the good results of the previous study, the study should be repeated
in order to further validate the new method in more patients and to obtain additional insight
with more measurements.
This single centre, observational comparative study shall investigate a new non-invasive ICP
absolute value measurement method in patients presenting with TBI, ICH, or secondary edema
after stroke or Subarachnoid Hemorrhage (SAH) compared to current standard invasive ICP
monitoring methods.Suitable patients are to be recruited soonest after their referral or
admission to the Department of Neurosurgery at the Kantonsspital Aarau. Measurement will be
done either at the surgical Intensive Care Unit, Stroke Unit ("SIC") or Neurosurgical
Intermediate Care Unit ("NCW"). All measurements will be performed on intubated and sedated
patients with invasive ICP Monitoring trough an intraparenchymatous or intraventricular
probe. In the same patient, several measurements will be allowed daily.
The non-invasive technique for measurement of ICP is based on simultaneously measuring of an
ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA)
segments of the OA with two-depth transorbital Doppler (TCD) measurements including
mechanical head frame for fixation of ultrasonic transducer on the closed eye lid. ICP
pressure will be measured non-invasively by using Vittamed 205® device. This device has CE
marking since July 2014.
It is planned to recruit 25 patients and to collect 69 independent paired non-invasive and
invasive ICP measurements during a 24 months period after study approval.
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