Cardiovascular Hemodynamics Processing System (CHAMPS)

总结/摘要 高血压是心血管疾病发病率和死亡率的主要原因， 高血压是一个全国性的问题，大约三分之一的成年人患有高血压（BP）。BP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。静态血压快照， 通常在医生就诊时通过血压测量获得， 问题，其原因包括白大褂高血压和技术差。因此，电子 戴在上臂上的血压测量装置，设计用于自我血压测量 （SBPM）已被广泛采用;然而，这些设备也存在测量可靠性差的问题。 很少根据指定的艾德指南执行（例如，在患者坐着的情况下进行测量， 手臂CU保持在心脏水平，手臂CU保持静止，并且不说话或腿交叉）。听诊 或基于铜的动态血压监测器（ABPM），可以在家庭环境中佩戴， 24小时内定期自动测量|最重要的是，在睡眠中|成为 临床标准，据报道提供更准确和可靠的结果。然而，这些设备仍然需要 患者遵循与SBPM相同的指南，仅产生间歇性测量（例如，每15-30分钟 白天，晚上每30-60分钟一次），并且许多患者发现这是突兀的和不舒服的。 申报的心血管血流动力学处理系统（CHAMPS）将是一种可靠、易于使用， 并且舒适（即，非Cu基）连续（即，逐搏）动态血压监测仪（cABPM）， 即使在日常生活活动（ADL）期间，也可以全天候工作。这种新型的BP监测仪将 一个重要的补充，临床实践，准确和不引人注目地评估个人与建立或 疑似高血压，即使在运动时，也没有不舒服的感冒。CHAMPS提供 准确的BP估计，而不限制用户的移动性，身体姿势或手臂抬高。在拟议的SBIR中， 在第一阶段，巴伦协会试图通过对以下方面的严格评估来证明CHAMPS的概念验证： 一种新的算法，消除了传统上与脉搏传导时间相关的重复校准的需要 （PTT）的系统。CHAMPS逐搏BP估计可以直接使用或在任意时间段上平均。 间隔（例如，以模仿常规ABPM）。在I期，CHAMPS收缩压、舒张压和平均动脉压 将比较在休息、不同姿势和手臂抬高以及跑步机运动期间获得的估计值 直接与标准BP测量值进行比较，标准BP测量值使用专门设计用于 在心脏负荷和运动测试中的应用。CHAMPS BP估计与准则的比较 将在两个50分钟的测试期间（间隔24小时）对每位参与者进行测量， 证明CHAMPS提供准确BP估计而无需重新校准的能力。CHAMPS将满 需要符合人体工程学、准确、可靠和低成本的cABPM，用于医疗保健和临床研究。 _

Summary/Abstract Hypertension is a leading cause of excess cardiovascular morbidity and mortality, and remains a signi cant national problem, with approximately one third of all adults having high blood pressure (BP). 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-oce visits, have documented reliability issues, the causes of which include \white-coat" hypertension and poor technique. As a result, electronic oscillometric devices that are worn on the upper arm and are designed for self blood pressure measurement (SBPM) have seen widespread adoption; however, these devices also su er from poor reliability as measurements are seldom performed according to the speci ed guidelines (e.g., measurements taken with the patient seated, arm cu maintained at heart level, arm cu kept stationary, and no talking or leg crossing). Auscultatory or oscillometric cu -based ambulatory BP monitors (ABPMs) that can be worn in home settings and provide regular automated measurements over 24 h periods|and, most importantly, during sleep|have become the clinical standard, reportedly providing more accurate and reliable results. However, these devices still require the patient to follow the same guidelines as SBPMs, yield intermittent measurements only (e.g., every 15-30 min during the day, every 30-60 min at night), and are found by many patients to be obtrusive and uncomfortable. The proposed Cardiovascular Hemodynamics Processing System (CHAMPS ) will be a reliable, easy-to-use, and comfortable (i.e., non-cu -based) continuous (i.e., beat-to-beat) ambulatory BP monitor (cABPM) that can operate around the clock, even during activities of daily living (ADL). 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 uncomfortable cu in ations. CHAMPS provides accurate BP estimates without restricting users' mobility, body postures, or arm elevations. In the proposed SBIR Phase I e ort, Barron Associates seeks to demonstrate proof-of-concept for CHAMPS via rigorous evaluation of a new algorithm that obviates the need for repeated calibrations traditionally associated with pulse transit time (PTT)-based systems. CHAMPS beat-to-beat BP estimates may be used directly or averaged over arbitrary intervals (e.g., to mimic conventional ABPMs). In Phase I, CHAMPS systolic, diastolic, and mean arterial BP estimates obtained during rest, di erent postures and arm elevations, and treadmill exercise will be compared directly with criterion BP measurements obtained using a clinical laboratory system speci cally designed for application in cardiac stress and exercise testing. Comparisons between CHAMPS BP estimates and criterion measurements will be obtained in each participant during two 50-min test periods separated by 24-h to demonstrate the ability of CHAMPS to provide accurate BP estimates without recalibration. CHAMPS will ful ll the need for an ergonomic, accurate, reliable, and low-cost cABPM for use in healthcare and clinical research. _