A novel instrument for continuous blood pressure monitoring

项目摘要/摘要 高血压是一个重大的公共健康问题，45%的成年人(75%的 65岁以上人群)，是心血管疾病发病率和死亡率过高的主要原因。血压监测 作为心血管疾病的重要标志物，具有较高的诊断和预后价值。静态BP快照， 通常是在医生就诊时通过血压计获得的，有文件证明是可靠的 问题，包括“白大褂”高血压和糟糕的技术。声学或振荡式袖带-- 可在家庭环境中佩戴并提供定期自动测量的激光血压监测仪(ABPM) 在超过24小时的时间里，人们广泛采用了这一技术。然而，这些设备也存在可靠性差的问题 因为即使在有训练的情况下也很少根据指定的指南来执行测量(例如， 坐好，双脚不交叉，胳膊袖口保持与心脏水平，等等)。它们也只能产生间歇性的衡量标准-- 睡眠(可能遗漏重要的血压事件)，由于它们的侵入性而恶化睡眠质量，使BP困惑 测量是由于对袖口充气的自主反应，而且是突出和不舒服的。 解决方案建议的血压SAGE(BP-SAGE)系统将是一种新的、可靠的、易于使用的、 舒适的(不基于袖口的)连续ABPM(CABPM)，可全天候运行，即使在以下活动期间也是如此 日常生活(ADL)和睡眠，不打扰或要求佩戴者采取任何行动，也不强迫 严格的测量指南。 这种新的血压监测仪将是对临床实践的重要补充，准确而不引人注目 评估确诊或怀疑患有高血压的个人，即使在运动期间和没有不适的情况下- 可容忍的袖口充气。BP-SAGE将提供准确的BP估计，而不会限制用户的移动性，身体 姿势，或手臂抬高。逐次BP估计可以直接使用，也可以通过任意方式求平均 间隔(例如，重现常规的ABPM结果)。 第一阶段的工作将通过严格的概念验证和BP-SAGE方法的可行性 对健康受试者和高血压受试者的评估。特别是，血压-SAGE收缩、舒张期和平均动脉 在休息时和在不同的血压水平下，将获得BP估计值，并与标准BP测量值进行比较 使用实验室级连续无创血压(CNIBP)监护仪获得。作为真实的脉冲传输时间 基于(PTT)的技术，并基于提出的新的建模方法，该方法也考虑了 血管舒缩张力，BP-SAGE将消除与传统脉冲到达相关的重复校准的需要 基于时间(PAT)的方法。BP-SAGE软件将自动生成符合以下条件的清晰、解释性报告 国际标准，包括摘要数据，以简化临床医生的解释。BP-SAGE将履行 需要符合人体工程学的、准确、可靠和低成本的连续血压监测，用于医疗保健和 临床研究。

Project Summary/Abstract Problem High blood pressure (BP) is a substantial public health problem that affects 45% of adults (75% of individuals over age 65) and is a leading cause of excess cardiovascular morbidity and mortality. BP monitoring has high diagnostic and prognostic value as an important marker of cardiovascular disease. Static BP snapshots, which are typically obtained via sphygmomanometry during doctor’s office visits, have documented reliability issues, including “white-coat” hypertension and poor technique. Auscultatory or oscillometric cuff-based ambu- latory BP monitors (ABPMs) that can be worn in home settings and provide regular automated measurements over 24-hour periods have seen widespread adoption. However, these devices also suffer from poor reliability because measurements are seldom performed according to the specified guidelines even with training (e.g., seated, feet not crossed, arm cuff maintained at heart level, etc.). They also yield only intermittent measure- ments (potentially missing important BP events), worsen sleep quality due to their intrusiveness, confound BP measurements due to autonomic response to cuff inflations, and are obtrusive and uncomfortable. Solution The proposed Blood Pressure Sage (BP-SAGE ) system will be a novel, reliable, easy-to-use, and comfortable (non-cuff-based) continuous ABPM (cABPM) that can operate 24/7, even during activities of daily living (ADL) and sleep without disturbing or requiring any action from the wearer, and without imposing stringent measurement guidelines. This new class of BP monitor will be an important addition to clinical practice, accurately and unobtrusively assessing individuals with established or suspected hypertension, even during movement and without uncom- fortable cuff inflations. BP-SAGE will provide accurate BP estimates without restricting users’ mobility, body postures, or arm elevations. The beat-to-beat BP estimates may be used directly or averaged over arbitrary intervals (e.g., to reproduce conventional ABPM results). The Phase I effort will demonstrate proof-of-concept and feasibility for the BP-SAGE methodology via rigorous evaluation in both healthy and hypertensive subjects. In particular, BP-SAGE systolic, diastolic, and mean arterial BP estimates will be obtained during rest and at different BP levels and compared to criterion BP measurements obtained using a laboratory-grade continuous noninvasive BP (cNIBP) monitor. As a true pulse transit time (PTT)-based technique, and based on the proposed novel modeling approach that also accounts for variations in vasomotor tone, BP-SAGE will obviate the need for repeated calibrations associated with traditional pulse arrival time (PAT)-based methods. BP-SAGE software will automatically generate clear, interpretive reports that meet international standards and include summary data to simplify interpretation by clinicians. BP-SAGE will fulfill the need for an ergonomic, accurate, reliable, and low-cost continuous BP monitoring for use in healthcare and clinical research.