A novel instrument for continuous blood pressure monitoring

一种新型连续血压监测仪器

• 批准号: 10696510
• 负责人: Brian R Clark
• 金额: $ 30.97万
• 依托单位: BARRON ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10696510
• 关键词: Activities of Daily Living; Adoption; Adult; Affect; Age; Algorithms; Altitude; Ambulatory Blood Pressure Monitoring; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Calibration; Cardiovascular Diseases; Cardiovascular system; Chest; Clinical; Clinical Research; Computer software; Custom; Data; Devices; Diagnostic; Diastolic blood pressure; Disease Management; Electrocardiogram; Error Sources; Evaluation; Event; Freedom; Goals; Guidelines; Healthcare; Heart; Heart Rate; Height; Home; Hour; Human; Hypertension; Individual; International; Intervention; Laboratories; Life; Marketing; Measurement; Measures; Medical; Methodology; Methods; Modality; Modeling; Monitor; Morbidity - disease rate; Movement; Noise; Office Visits; Patients; Pattern; Phase; Physiologic pulse; Physiological; Polynomial Models; Posture; Protocols documentation; Public Health; Reporting; Research; Rest; Secure; Sleep; Small Business Innovation Research Grant; Specific qualifier value; Statistical Data Interpretation; System; Techniques; Technology; Therapeutic Intervention; Time; Training; Tube; Variant; Vasomotor; Wrist; arm; arterial stiffness; blood pressure variability; blood product; cardiovascular disorder prevention; clinical practice; cloud based; cost; dashboard; data quality; design; diagnostic value; ergonomics; foot; hemodynamics; human old age (65+); hypertensive; improved; improved outcome; indexing; innovation; instrument; instrumentation; mortality; next generation; novel; phase 2 designs; power analysis; pressure; prognostic value; programs; prospective; prototype; remote grading; research and development; response; sensor; sleep quality; smart watch; telemonitoring; transmission process; usability; white coat hypertension; wireless; Activities of Daily Living; Adoption; Adult; Affect; Age; Algorithms; Altitude; Ambulatory Blood Pressure Monitoring; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Calibration; Cardiovascular Diseases; Cardiovascular system; Chest; Clinical; Clinical Research; Computer software; Custom; Data; Devices; Diagnostic; Diastolic blood pressure; Disease Management; Electrocardiogram; Error Sources; Evaluation; Event; Freedom; Goals; Guidelines; Healthcare; Heart; Heart Rate; Height; Home; Hour; Human; Hypertension; Individual; International; Intervention; Laboratories; Life; Marketing; Measurement; Measures; Medical; Methodology; Methods; Modality; Modeling; Monitor; Morbidity - disease rate; Movement; Noise; Office Visits; Patients; Pattern; Phase; Physiologic pulse; Physiological; Polynomial Models; Posture; Protocols documentation; Public Health; Reporting; Research; Rest; Secure; Sleep; Small Business Innovation Research Grant; Specific qualifier value; Statistical Data Interpretation; System; Techniques; Technology; Therapeutic Intervention; Time; Training; Tube; Variant; Vasomotor; Wrist; arm; arterial stiffness; blood pressure variability; blood product; cardiovascular disorder prevention; clinical practice; cloud based; cost; dashboard; data quality; design; diagnostic value; ergonomics; foot; hemodynamics; human old age (65+); hypertensive; improved; improved outcome; indexing; innovation; instrument; instrumentation; mortality; next generation; novel; phase 2 designs; power analysis; pressure; prognostic value; programs; prospective; prototype; remote grading; research and development; response; sensor; sleep quality; smart watch; telemonitoring; transmission process; usability; white coat hypertension; wireless

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.

项目摘要/摘要 问题高血压（BP）是一个实质性的公共卫生问题，影响了45％的成年人（占成年人的75％ 个人超过65岁），是心血管发病率过多的主要原因。 BP监视 作为心血管疾病的重要标志，具有高诊断和预后价值。静态BP快照， 通常在医生办公室访问期间通过血压计获得，已记录了可靠性 问题，包括“白涂”高血压和技术差。听诊或振荡袖口 可以在家庭设置中佩戴并提供常规自动测量的Latory BP监视器（ABPMS） 在24小时的时间内，采用了宽度。但是，这些设备的可靠性也很差 因为即使在培训中，也很少会根据指定准则进行测量（例如， 坐着，脚没有交叉，保持心脏水平的手臂袖子等）。它们还仅产生间歇性测量 - 不幸的是，由于其侵入性而导致睡眠质量（可能缺少重要的BP事件），BP混淆 由于对袖口通胀的自主反应而导致的测量，并且令人难以置信且不舒服。 解决方案建议的血压鼠尾草（BP-SAGE）系统将是一种新颖，可靠，易于使用的，并且 即使在活动中 日常生活（ADL）和睡眠而无需打扰或需要穿佩戴者的任何行动，而无需施加 严格的测量指南。 这类新型的BP监视器将是临床实践的重要补充 评估患有已建立或怀疑性高血压的人，即使在运动期间，也没有 稳定的袖口通货膨胀。 BP-SAGE将提供准确的BP估计值，而无需限制用户的移动性，身体 姿势或手臂高度。 Beat-to-Beat BP估计可以直接使用或通过任意平均 间隔（例如，重现常规ABPM结果）。 第一阶段的努力将通过严格的概念证明和可行性证明和可行性 对健康和高血压受试者的评估。特别是BP-SAGE收缩期，舒张压和平均动脉 BP估计值将在休息和不同的BP水平上获得，并将其与标准BP测量进行比较 使用实验室级连续无创BP（CNIBP）监视器获得。作为真正的脉冲运输时间 基于（PTT）的技术，并基于提出的新型建模方法，该方法也解释了变化 血管舒张态，BP-SAGE将消除与传统脉冲到达相关的重复校准的需求 时间（PAT）的方法。 BP-SAGE软件将自动生成明确的解释性报告 国际标准，包括简化临床医生解释的摘要数据。 BP-SAGE将实现 需要进行符合人体工程学，准确，可靠和低成本连续的BP监控，以用于医疗保健和 临床研究。