A Prospective Clinical Trial to Evaluate an Automated Cerebral Ventricular Drainage System in Patients in the Neurointensive Care

This is a prospective, randomised trial to evaluate a new medical device for automated zero calibration of ventricular drainage systems in neurointensive care patients. Patients will be randomised into the medical device group, or a control group with a standard system for ventricular drainage. All patients will be fitted with an intraparenchymal ICP monitor, and an ICP monitor connected to the ventricular catheter. Since ICP monitoring using the ventricular catheter system is reliant upon regular zero-calibrations of the system in relation to the mid-point of the patient head, the ICP value from the intraparenchymal ICP monitor will be used as standard, and the intra-ventricular ICP measurements will be compared to this ICP. The difference in ICP between the two ICP monitors will be the primary outcome for this trial, where the medical device tested is designed to constantly zero-calibrate the ventricular catheter in relation to the patients´ head. Secondary outcome of this trial will be number of manual zero-calibrations performed, and number of automated zero-calibrations performed by the device, and AE, SAE and DDs.