Approximately 3 million individuals suffer from traumatic brain injury (TBI) annually, with over 50,000 expected to die as a result of their injury. In these most severe cases, patients are typically admitted to the intensive care unit (ICU) for continuous monitoring and treatment of their injury. Standard monitoring includes implantation of an intracranial pressure (ICP) sensor, arterial blood pressure (ABP) monitoring, and occasional imaging studies (typically with CT). The objective of these monitoring strategies is to detect evolving pathology in a timely manner so that treatment can be provided to these patients prior to their injury escalating to a point at which treatment becomes ineffective. Unfortunately, these strategies are limited in their ability to detect worsening conditions. Spiking ICP represents a global measure of worsening status, however it provides no localizing information and typically reaches levels of concern (>20 mmHg) much later than is clinically desired. ABP sensing coupled with ICP represents a surrogate measure of cerebral perfusion pressure, but is difficult to accurately gauge. Occasional image studies provide exquisite intracranial details, but are difficult to administer in heavily instrumented ICU patients and are only acquired occasionally, often after injury has begun to progress. We propose to overcome the limitations of current monitoring strategies by developing a small form- factor, real-time continuous monitor, able to spatially map evolving intracranial trauma. Specifically, we propose to use an adapted form of electrical impedance spectroscopy for this purpose. Our novel approach leverages both scalp and intracranial electrodes to map dynamic intracranial impedance changes associated with fluid and tissue alterations resulting from trauma. We have demonstrated in a pilot animal study that this type of modality is capable of detecting intracranial changes due to mass effect, hematoma, and brain death. During this program we will take the significant step of developing this technology for commercial deployment and demonstrating proof of feasibility in an animal model using intraoperative CT scanning. Because this system is being designed to minimally augment an already existing clinical protocol (designed to interface with a heavily instrument patient in the ICU), is relatively inexpensive (
Public Health Relevance Statement: PROJECT NARRATIVE Current clinical practices using continuous intracranial pressure (ICP) monitoring along with CT images acquired every few hours to monitor patients with TBI unfortunately do not provide clinicians with early enough warning to adequately treat evolving injury. Bioimpedance sensing is a method by which intracranial pathology can be safely and continuously monitored in patients with TBI. We have demonstrated that bioimpedance signatures are related to this evolving TBI pathology; we aim to take the significant step of designing a marketable impedance-sensing device that can be used in the intensive care unit (ICU) and demonstrating feasibility of device deployment in a novel animal model.
Project Terms: Adverse event; Algorithms; Animal Model; Animals; base; Blood; blood perfusion; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Brain; Brain Death; brain health; Brain Injuries; Brain Ischemia; Businesses; Capital; cerebral oxygenation; Cerebral perfusion pressure; Cerebrospinal Fluid; Clinic; Clinical; clinical practice; Clinical Protocols; Clinical Research; college; commercialization; Coupled; Custom; Data; design; Devices; electric impedance; Electrocardiogram; Electrodes; Electroencephalography; Equipment; evidence base; Evolution; foot; Frequencies; Growth; Hematoma; Hemorrhage; Hospitalization; Hour; Hypotension; Image; imaging study; Implant; implantation; improved; Individual; Injury; instrument; instrumentation; Intensive Care Units; Intracranial Pressure; Ionizing radiation; Legal patent; Liquid substance; Manuals; Maps; Marketing; Measurement; Measures; Medical; meetings; Methodology; Methods; Modality; Monitor; neurovascular; novel; novel strategies; Outcome; Pathology; Patient Monitoring; Patients; Performance; Phase; Positioning Attribute; pressure; Pressure Transducers; Printing; Procedures; programs; Research Design; Resolution; Sample Size; Sampling; Scalp structure; Scanning; sensor; Small Business Technology Transfer Research; soft tissue; Spectrum Analysis; Speed; Swelling; System; TBI Patients; Techniques; Technology; temporal measurement; Testing; Time; Tissues; Translating; Trauma; Traumatic Brain Injury; trend; X-Ray Computed Tomography
