TBI and SAH patients, one arm

A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)

Feasibility:

User acceptance: For NeMo Probes in comparison to conventional probes for intracranial pressure (ICP-) monitoring; for NeMo Patch in comparison to patches for electroencephalography (EEG) monitoring.

Detailled evaluation of user acceptance:

• Incidence of concerns of users in relation to the installation, function and removal of the NeMo System (= NeMo Probe, NeMo Patch, NeMo Control Unit and NeMo Software pre-installed on a Medical PC)
• User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional devices

Accuracy of measurements:

-Patients: Results from repeated measurements of mean transit time of ICG (mttICG), cerebral blood flow (CBF) and cerebral blood volume (CBV)

Safety parameters:

Incidence of complications (infections, brain tissue damage, haemorrhage) compared to historical series (patches for EEG and for BIS measurements; conventional probes for ICP monitoring)

Results concerning sensitivity and specificity to detect symptomatic vasospasm in patients with subarachnoid hemorrhage (SAH) (correlation of events with CBF values < 15 ml/100g/min with defined criteria for vasospasm) Results concerning sensitivity and specificity to detect secondary infarctions and critical ICP values in TBI patients (correlation of events with CBF values < 15 ml/100g/min with defined criteria for secondary infarction) Results from repeated measurements for the difference between measurement values obtained with the NeMo Patch and the NeMo Probe, quantified with mathematical models