Development of a Novel Autonomous Non-invasive Absolute Intracranial Pressure (aICP) Measurement Device Based on Ultrasound Doppler technology
BrainSafe II is an EU-funded project for development of the innovative technology for non-invasive fast-and-easy, accurate and precise absolute intracranial pressure (aICP) diagnostics. The project runs according to EC FP7 Research for Benefit of SME’s programme with the full name “Development of a Novel Autonomous Non-Invasive Absolute Intracranial Pressure Measurement Device Based on Ultrasound Doppler Technology”. The project runs for two years starting on September 2012.
The primary aim of treatment and critical care for patients suffering of neurological diseases or brain injuries is to closely monitor the patient state and provide appropriate therapeutic intervention. A key component of such monitoring involves measurement of intracranial pressure (ICP). ICP is a central variable – a vital sign – in neurological diagnosing and monitoring because of its importance in intracranial dynamics, its direct effect on cerebral perfusion, and its correlation with prognosis and outcome in different groups of patients.
Innovative non-invasive ultrasound based ICP measurement technology BrainSafe II addresses this need and offers the non-invasive ICP meter for routine clinical care – an autonomous, rapid, accurate and precise device for measurement of absolute (quantitative) ICP without the need to calibrate the device for individual patient. The Brainsafe II project achieved significant scientific and technological results including the developed enhanced ultrasound Doppler system, optimized signal processing and filtering algorithms, novel pressurization and automatic electromechanical ultrasonic transducer spatial positioning system. Fully integrated and automatic system for non-invasive ICP measurement by non-experts was created during the project. The automatic operation of the device eliminates the need for highly qualified personnel which would otherwise create a bottleneck in the adoption and application of the device.
The impact of this technology will be highly significant across a wide spectrum of levels. The clinical impact will mean improvement in the diagnosis and treatment of neurosurgical and neurological diseases. Earlier, faster and more accurate diagnosis will save lives and prevent disability. The innovative technology will open up possibility for use in several settings where ICP monitoring would improve care, but it’s currently avoided because of complexity or highly invasive nature of available methods. A much greater number of patients than before will benefit from screening by this technological breakthrough because it will not be necessary to have highly trained personnel operating the device.
The pre-clinical research of Brainsafe II technology was carried out in consideration of best practice guidelines for healthy volunteers. The device testing was performed in accordance with the principles of the Declaration of Helsinki. The study protocol and methodology was prepared together with Lithuanian University of Health Sciences. An approval of Kaunas Regional biomedical research ethics committee was granted. Preclinical study of the developed Brainsafe II device was performed on 20 healthy volunteers in order to test the correct functioning and operation of the Brainsafe II and to validate the automatic operation and functionality of the device. It has been shown experimentally that novel BrainSafe II robotic probe, it’s control algorithm and created software operate according to technical specifications. The operation of the Brainsafe II device is stable and repeatable.
The BrainSafe II consortium partners contributed expert manpower and state of the art equipment, facilities and team competences required to achieve the main objectives of the project. The project was carried out by a consortium of field experts within ultrasonic techniques, signal processing and ergonomic hardware design and manufacturing ensuring coverage of all the key components for successful implementation of the project and supply chain capacities to exploit the results thereafter.
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