Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
1
Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.
Inselspital Bern
Bern, Canton of Bern, Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Canton of Vaud, Switzerland
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD.
Time frame: Up to 28 days until probe removal
Safety related to catheter insertion and monitoring
Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.
Time frame: Until 7 days after probe removal
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