Can Crainio’s probe be redesigned for use in pre-hospital care settings, while demonstrating non-inferiority to the existing probe through bench and in vivo testing?

Traumatic Brain Injury(TBI) commonly causes high intracranial pressure(ICP) because bleeding and brain swelling is confined within the rigid skull. High ICP can cause secondary brain injury, increasing disability/mortality. Guidelines recommend patients at risk of raised ICP have their ICP monitored for ~72 hours after TBI so timely interventions can be made to reduce ICP and prevent secondary injury. Currently, ICP can only be monitored once a patient reaches hospital because the two currently available methods for ICP monitoring require specialist hospital resources: Surgical equipment/facilities to drill a small hole in the skull and insert an electrical sensor into brain tissue for continuous/quantitative ICP monitoring(gold-standard method). CT/MRI scanners for intermittent/qualitative ICP monitoring. In hazardous/complex situations(snow, traffic pile-ups, etc.) it can be multiple hours between emergency medical services arriving at the accident scene and the patient arriving at hospital. But best patient outcomes occur when specialist hospital-level care begins within the initial "golden hours" after injury[Howard21,Abhilash20,Dinh13]. Neurosurgeons have told us that accessing ICP data from the golden hours prehospital, i.e. data collected by emergency services personnel at the scene of an accident, in addition to data collected in hospitals, would: Better inform which patients require transport to a farther-away specialist hospital vs. closer general hospital, Enable more effective/prioritised clinical management of non-head injuries, where ICP is confirmed as normal, Improve/speed up clinical decisions about the optimal intervention for each patient(i.e. personalised medicine) where ICP is found to be elevated, improving clinical outcomes, Avoid expensive diagnostic pathways where ICP is confirmed as normal, reducing costs, Reduce reliance on highly specialist personnel(aligning with NHS Workforce Plan requirements). Discussions with emergency clinicians/paramedics indicate their eagerness to upskill and improve TBI patient outcomes. Crainio is developing a non-invasive ICP monitor that shines harmless near-infrared light through the skull and into the brain and detects an optical signal directly related to ICP. The monitor comprises a disposable probe containing light source and detectors, a small control unit, and user interface for displaying ICP(calculated using machine-learning algorithms). Its small, portable, non-invasive nature opens up the opportunity for prehospital(golden-hours) ICP monitoring, aligning with this FAST call s scope as "innovative healthcare technology for[…] management of[…] acquired brain injury[…] in health and care settings or[…] where the ABI incurred". Prototypes of our device have been tested in in-vitro[Roldan23-1], in-vivo (healthy volunteers)[Roldan23-2] and clinical studies[Roldan24], where ±3.8mmHg Bland-Altman limits-of-agreement and high sensitivity(79%) and specificity(89%) for detecting raised ICP were achieved using data from 40 TBI patients in ICU. The probe has been further developed for hospital environments(funded by NIHR205657), and data is being collected with this improved probe to increase accuracy of the machine-learning ICP estimations(ClinicalTrials.gov NCT06453733). Minor probe hardware enhancements are required to optimise the probe for the harsher conditions encountered in prehospital care (at the scene of an accident). We work with brain injury charity Headway. We have conducted technology and study assessments with their members, e.g. we have rewritten patient information sheets to be more understandable for patients with cognitive impairments caused by TBI.