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 towards a 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 conventional 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 Spearman Correlation test was applied. In addition, as part of a post-hoc analysis, we evaluated patient outcomes. Results : Thirty patients were included in the study. After calculating the median absolute difference between the intraparenchymal and the intraventricular measured ICP, the VGuard® system provided better accuracy in measured intracranial pressure (p<0.001). The improved accuracy was further supported by the median of correlation coefficients in the group of participants receiving the VGuard® system (p<0.05). Additionally, no serious adverse events were noted by the VGuard® system. There were no statistically significant differences in patient outcomes between the two groups. Conclusions : This is the first study to evaluate the VGuard® system, showing results of increased accuracy in measured ICP compared to the conventional EVD. The VGuard® system offers an automated EVD solution, representing a pivotal step towards increased neurointensive care automation and potentially reducing complications observed when conventional, manual EVD systems are used. Trial registration : NCT05177692. ClinicalTrials.gov. Registered 14 December 2021, https://clinicaltrials.gov/study/NCT05177692.