Evaluation of a Novel Automated Cerebral Ventricular Drainage System for Intracranial Pressure Monitoring and Cerebrospinal Fluid Drainage in Neurocritical Care Patients: A Prospective, Randomized Clinical Study.

BACKGROUND

Neurointensive care is moving toward more automated patient management. This study aimed to evaluate a novel external ventricular drainage (EVD) system, the VGuard® system, as a tool for intracranial pressure (ICP) monitoring and automating ventricular drainage of cerebrospinal fluid (CSF), focusing on its safety and potential to reduce complications associated with manual EVD management.

METHODS

This prospective, randomized clinical study was conducted in the Department of Neurosurgery at Skåne University Hospital, Lund, Sweden. Patients (aged > 18 years) with different acute brain pathologies requiring an EVD were enrolled and randomized (1:1) to receive the VGuard® system or a manual EVD. Both systems employed a ventricular probe for simultaneous intraventricular and intraparenchymal ICP monitoring. Measurement accuracy was determined by comparing the median of absolute difference in ICP, using the Mann-Whitney U test. To further investigate the accuracy of ICP measuring, a post hoc Spearman correlation test was applied. In addition, as part of a post hoc analysis, we evaluated patient outcomes.

RESULTS

A total of 30 patients were included in the study. The VGuard® system demonstrated significantly better accuracy in ICP measurements compared with the manual EVD; median absolute difference: 1.07 versus 2.88, p < 0.001; median Spearman correlation coefficients: 0.81 versus 0.48, p < 0.05. There were no statistically significant differences in patient outcomes [mortality, Glasgow Outcome Scale-Extended (GOSE), modified Rankin Scale (mRS), median time with the EVD, and length of intensive care unit (ICU) stay], or adverse events (AE). No serious adverse events were noted.

CONCLUSIONS

This is the first study to evaluate the VGuard® system, showing results of increased accuracy in measured ICP compared with the manual EVD. The VGuard® system offers an automated EVD solution, representing a step toward increased neurointensive care automation.