Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development
The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring. This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury. The primary objective is to establish the diagnostic accuracy of the Crainio device, aiming for at least 90% sensitivity and specificity in detecting raised ICP (above 20 mmHg). Secondary objectives include evaluating patient-related factors such as skin tone, skull thickness, and skull density, as well as the tolerability and acceptance of the device by both patients and healthcare professionals.
• Clinical diagnosis of traumatic brain injury.
• Adults (aged between 16 and 99, male and female)
• TBI patients admitted to the Royal London Hospital.
• Patients having invasive ICP monitoring as part of their normal medical treatment.