Novel engineering solutions for easy and accurate manual blood pressure measurement

高血压是导致冠心病、充血性心力衰竭、肾病和中风的主要心血管危险因素之一。它是英国30%死亡的一个促成因素，每年有400万NHS床位。《美国医学会杂志》（JAMA）的一项主要综述估计，5 mmHg的误差将导致2100万美国人被拒绝接受治疗，或2700万人接受不必要的治疗，具体取决于误差的方向。血压测量的重要性毋庸置疑，但它仍然是临床实践中表现最差的诊断测量之一。血压测量手册听诊血压测量在过去的100年里变化不大。它包含三个主要元件：袖带、压力显示器和听诊器。袖带环绕上臂以闭塞肱动脉，并通过控制装置放气，使血液在压力释放时再次流动。尽管，或者也许是因为，它的简单性，它仍然是最准确的测量技术。现行国际标准表明，与手动测量相比，自动血压设备可能具有+/- 16 mmHg（95%置信区间）的不准确性，这不足以用于临床诊断决策。三个主要的欧洲临床学会的指南解决了重新建立手动测量的必要性。英国卫生部发布了一项医疗器械警报，要求所有临床用户都能使用手动设备，以便在需要时进行准确的测量。研究问题手动测量高度依赖于训练有素的用户使用听诊器识别与收缩压和舒张压（SBP和DBP）相关的柯氏音的技能。拟议的研究将开发新的工程解决方案，以实现轻松准确的手动血压测量。SME协作申请人是英国标准协会血压计委员会主席，并代表英国参加国际标准委员会（国际标准化组织和国际电工委员会联合），在该领域活跃超过25年。我们的纽卡斯尔研究小组与英国唯一的血压计制造商AC Cossor & Son（Surgical）Ltd家族公司密切合作，成功地生产了新型电子专利Accoson greenlight 300，该产品具有非常清晰的显示屏，使测量的阅读更加容易，并显示袖带放气率（也获得专利）。这些功能产生了巨大的改进，并由英国工业领导。唯一需要改进的是听诊器的使用。这很复杂，在提出任何新的原型装置之前需要进行大量的基础研究。我们的目标在本提案中，我们将研究技术，以帮助和改善手动血压测量中的收缩期和舒张期的识别。这项研究将研究我们现有的独特的记录Korotkoff声音数据库，开发算法，以帮助强调收缩期和舒张期Korotkoff功能的关键差异，建立一个实验室系统，允许调查其他传感器，调查更多的歧视性方式呈现传感器输出，并前瞻性地评估所提出的技术。有巨大的空间来改善这个100岁的声学技术。

Clinical need High blood pressure is one of the leading cardiovascular risk factors for coronary artery disease, congestive heart failure, renal disease and stroke. It is a contributory factor in 30% of all deaths in the UK, with 4 million NHS bed days annually. A major review in the Journal of the American Medical Association (JAMA) estimated that a 5 mmHg error would result in 21 million Americans being denied treatment or 27 million being exposed to unnecessary treatment, depending on the direction of the error. The importance of blood pressure measurement is without doubt, but it is still one of the most poorly performed diagnostic measurements in clinical practice.Blood pressure measurement Manual auscultatory blood pressure measurement has changed little over the past 100 years. It contains three main elements: a cuff, pressure display and stethoscope. The cuff encircles the upper arm to occlude the brachial artery, and is deflated with a control, allowing the blood to flow again as the pressure is released. In spite of, or perhaps because of, its simplicity, it is still the most accurate measurement technique. The current International Standards shows that automated blood pressure devices can have an inaccuracy in comparison with manual measurement of +/- 16 mmHg (95% confidence interval), which is not adequate for clinical diagnostic decisions. Guidelines from the three main clinical European Societies addressed the need to re-establish manual measurement. This was further reinforced by the UK Department of Health when they issued a Medical Device Alert, requiring all clinical users to have access to a manual device so that accurate measurements are taken when required.The research problem Manual measurement relies highly on the skills of the trained users to identify the Korotkoff sounds associated with systolic and diastolic blood pressure (SBP and DBP) using the stethoscope. The proposed research will develop novel engineering solutions to achieve easy and accurate manual blood pressure measurement. SME collaboration The applicant is Chair of the British Standards Institute committee on sphygmomanometers and represents the UK on the International Standards Committee (joint International Organization for Standardization, and International Electrotechnical Commission) and has been active in this field for over 25 years. Our Newcastle research group has worked with the only UK manufacturer of sphygmomanometers, the family firm AC Cossor & Son (Surgical) Ltd, cooperating closely and successfully to produce the novel electronic patented Accoson greenlight 300 with a very clear display to make the reading of the measurement much easier, and to display the cuff deflation rate(also patented). These features have produced dramatic improvements, and have been led by UK industry. The only feature still to be improved is the use of the stethoscope. This is complex and requires much basic research before any new prototype device could be proposed. Our proposal to this Healthcare Partnerships will tackle this problem.Our goal In this proposal we will research techniques to aid and improve the identification of systole and diastole in manual blood pressure measurement. This research will study our existing unique database of recorded Korotkoff sounds, develop algorithms to help accentuate key differences in Korotkoff features at systole and diastole, set up a laboratory system to allow investigation of other sensors, investigate more discriminatory ways of presenting the sensor output, and prospectively evaluate the techniques proposed. There is enormous scope for improving this 100 year old acoustic technique.