The Correlation Between FlowSense Flow Rate Measurements and EVD Drainage Data and Intracranial Pressure (ICP) Measurements

What this Trial Is About

Researchers are studying hydrocephalus, a serious condition caused by excess cerebrospinal fluid (CSF) in the brain. This condition can cause symptoms like lethargy, seizures, and coma. Standard treatment involves surgically implanted shunts to drain the fluid, but these often fail, leading to repeated emergency visits and surgeries. Current diagnostic tools like CT and MRI scans are costly and sometimes inconclusive. The study aims to evaluate FlowSense, a new wireless, noninvasive device designed to monitor CSF flow in shunts easily and without expensive equipment. FlowSense is a small, soft silicone sensor worn on the neck over the shunt site. It detects the presence and amount of CSF flow and wirelessly sends data to a mobile app. The study includes patients who already have one or more external ventricular drains (EVDs). Researchers will compare FlowSense measurements with data from EVD drainage and intracranial pressure (ICP) monitors. This study is non-randomized and includes two phases: one to test video recording of CSF drainage and another to explore correlations between FlowSense data, drainage volumes, ultrasound skin thickness, and ICP waveforms. Participants will have their CSF drainage monitored via video and FlowSense sensor readings during hospital stays. Data collection includes measuring drainage volume over 20 minutes, ultrasound skin thickness over the EVD, and recording ICP waveforms. Each patient may be assessed multiple times during admission. The study will measure exploratory outcomes and assess the suitability of the digital video recording system over one year. The total participation time varies depending on hospital admission and assessments.

EVD Drainage Data and Intracranial Pressure (ICP) Measurements