Taylor, Natasha

Coventry University Pure Portal

 0006 CEREBROTECH™     VISOR  REAL-TIME                  ASSESSMENT OF BRAIN INJURY TO PROVIDE                         ADDITIONAL                   INFORMATION AND FACILITATE EARLY INTERVENTION     FOR FURTHER INFORMATION PLEASE CONTACT: TRAUMA MIC www.trauma.htc.nihr.ac.uk TraumaMedTechCooperative@uhb.nhs.uk @TraumaMedTechCooperative  CASE STUDY CEREBROTECH MEDICAL SYSTEMS www.cerebrotechmedical.com info@cerebrotechmedical.com  +1-925-399-5392 NIHR TRAUMA MIC www.traumamic.nihr.ac.uk  traumamic@uhb.nhs.uk  PROJECT SUMMARY  The NIHR Trauma Management MedTech Co-operative (NIHR Trauma MIC) has collaborated with Cerebrotech   Medical Systems in the evaluation of the Cerebrotech Visor, a non-invasive device consisting of a scanner, console and  disposables. The device uses Volumetric Impedance     Phase-shift Spectroscopy (VIPS™) technology which         provides real-time assessment of the brain’s status following strokes and other brain injury, potentially facilitating earlier intervention. Changes in the brain’s fluids, such as those  involved in stroke, bleeding, or oedema, can be detected by monitoring fluctuations in intracranial electrical properties, called bioimpedance. These changes are detected by          measuring the alterations in low-power (less than that of a mobile phone) radio waves generated by the device as they pass through the head.  CLINICAL NEED  According to NICE Clinical Guideline 176 (2014):    Head injury is the commonest cause of death and        disability in people aged 1–40 years in the UK. Each year, 1.4 million people attend emergency departments in    England and Wales with a recent head injury. Annually, about 200,000 people are admitted to hospital with head injury, of these, one-fifth have features suggesting skull fracture or have evidence of brain damage.   Emergency departments see a large number of patients   with minor or mild brain injuries such as stroke, and need to         rapidly identify the small percentage of people who may have or will go on to develop serious acute intracranial            pathologies. Providing a fast, non-invasive method of               detecting complications in these patients could greatly            improve the efficiency of treatment for head injury.  THE SOLUTION  Cerebrotech Visor, utilizing VIPS, is a bioimpedance               spectroscopy device that non-invasively detects changes in intracranial fluids. It is indicated for patients who are at risk for cerebral oedema and is intended as an aid to              physiologic assessment in conjunction with clinical               judgment and current standards of care. In addition, the    Visor non-invasively detects bioimpedance asymmetry,   including asymmetry associated with large acute ischemic stroke in patients who are being evaluated for acute stroke. Because the Visor is robust, portable, and non-invasive, it can be used as a valuable adjunctive clinical monitoring    instrument in a variety of settings   HOW WE SUPPORTED  Provided advice pertaining to the introduction of the Visor into European markets, and associated             product beta testing  Supported applications for grant funding  Undertook a feasibility study in healthy volunteers to determine how changes in head position alter the device readings  Orchestrated a usability study to assess how nursing and clinical staff experienced fitting the device onto a simulated patient  Additionally, we facilitated a study, in collaboration with Coventry University, to investigate the usability of the  device with 16 paramedics (consisting of lecturers and second year paramedic students) within Coventry            University’s Science and Health Building’s ambulance simulator facility. Assistance provided encompassed:   Usability testing strategy and plan: formative (observational) study  Evaluation and risk assessment of the user interface (UI)  Recruitment of representative test participants  Relevant documentation preparation e.g. consent forms  Effective moderation of the usability test  Data management, analysis, and UI recommendations  The results of the usability work have led to valuable             feedback, and ongoing improvements being implemented into the device.   The device is CE marked and cleared by the U.S. Food and Drug Administration.   REFERENCES  National Institute for Health and Clinical Excellence (2014) Head injury: assessment and early management. NICE                    guideline (CG176)  

Cerebrotech™ Visor:Real-time assessment of brain injury to provide additional information and facilitate early intervention.

https://pure.coventry.ac.uk/ws/files/19182921/Cerebrotech_Case_Study.pdf

Cerebrotech™ Visor:Real-time assessment of brain injury to provide additional information and facilitate early intervention.

Abstract

Similar works

Full text

Available Versions

Coventry University Pure Portal