Cardiovascular Hemodynamics Processing System (CHAMPS)

心血管血流动力学处理系统（CHAMPS）

基本信息

批准号：
9409408
负责人：
B EUGENE PARKER
金额：
$ 22.5万
依托单位：
BARRON ASSOCIATES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9409408
关键词：
ARNT gene Activities of Daily Living Adoption Adult Age Algorithms Ambulatory Blood Pressure Monitoring Beds Blood Pressure Blood Pressure Monitors Blood Vessels British Calibration Cardiac Cardiovascular Diseases Cardiovascular system Cellular Phone Chest Clinical Clinical Research Computers Data Development Devices Diagnostic Disease Management Early Diagnosis Electrocardiogram Electrodes Electronics Elements European Evaluation Event Exercise Exercise stress test Exertion Freedom Goals Guidelines Health Care Research Health Personnel Heart Home environment Human Hypertension Individual Kidney Laboratories Left Leg Legal patent Life Maintenance Maps Measurable Measurement Measures Medical Modeling Monitor Morbidity - disease rate Movement Nail plate Obesity Participant Patients Phase Photoplethysmography Physiologic pulse Posture Process Protocols documentation Radio Research Rest Sampling Severities Side Signal Transduction Sleep Small Business Innovation Research Grant Societies Stress System Tablets Techniques Technology Testing Thumb structure Time Upper arm Validation Visit Wireless Technology Work Wrist arm base cardiovascular disorder prevention cardiovascular risk factor clinical application clinical practice comparative cost design flexibility hemodynamics instrumentation interest mortality novel power analysis pressure prognostic value programs prototype sensor success systems research transmission process treadmill white coat hypertension

项目摘要

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. _

摘要/摘要高血压是心血管发病率和死亡率过高的主要原因，并且仍然是一个重要的原因全国性问题，大约三分之一的成年人患有高血压（BP）。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。静态血压快照，通常是在医生就诊期间通过血压测量获得的，具有记录的可靠性问题的根源包括“白大褂”高血压和技术差。因此，电子佩戴在上臂上的示波设备，专为自我血压测量而设计（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指南进行测量（例如，在患者坐着的情况下进行测量，手臂保持在心脏水平，手臂保持静止，不要说话或交叉双腿）。听诊法或基于铜的示波动态血压监测仪 (ABPM)，可在家庭环境中佩戴并提供 24 小时内定期自动测量|最重要的是在睡眠期间|已成为临床标准，据报道可提供更准确、更可靠的结果。然而，这些设备仍然需要患者遵循与 SBPM 相同的指南，仅进行间歇性测量（例如，每 15-30 分钟一次）白天，晚上每 30-60 分钟一次），许多患者发现这种做法很碍眼且不舒服。拟议的心血管血流动力学处理系统（CHAMPS）将是一个可靠、易于使用、舒适（即非基于 cu）的连续（即逐次心跳）动态血压监测仪 (cABPM) 可以全天候运行，甚至在日常生活活动 (ADL) 期间也是如此。这种新型血压监测仪将对临床实践的重要补充，准确且不引人注目地评估具有已建立或怀疑高血压，即使在运动过程中并且没有不舒服的感觉。 CHAMPS提供准确的血压估计，而不限制用户的活动能力、身体姿势或手臂抬高。在拟议的 SBIR 中在第一阶段的努力中，Barron Associates 试图通过严格的评估来证明 CHAMPS 的概念验证一种新算法，无需传统上与脉冲传输时间相关的重复校准基于 (PTT) 的系统。 CHAMPS 逐搏血压估计可直接使用或对任意值进行平均间隔（例如，模仿传统的 ABPM）。在第一阶段，CHAMPS 收缩压、舒张压和平均动脉血压将比较休息、不同姿势和手臂抬高以及跑步机锻炼期间获得的估计值直接使用专门设计的临床实验室系统获得的标准血压测量值在心脏负荷和运动测试中的应用。 CHAMPS BP 估计值与标准之间的比较每个参与者将在两个 50 分钟的测试期间（相隔 24 小时）进行测量证明 CHAMPS 无需重新校准即可提供准确血压估算的能力。 CHAMPS将满足医疗保健和临床研究中需要一种符合人体工程学、准确、可靠且低成本的 cABPM。 _