A novel instrument for continuous blood pressure monitoring
一种新型连续血压监测仪器
基本信息
- 批准号:10696510
- 负责人:
- 金额:$ 30.97万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Activities of Daily LivingAdoptionAdultAffectAgeAlgorithmsAltitudeAmbulatory Blood Pressure MonitoringBlood PressureBlood Pressure MonitorsBlood VesselsCalibrationCardiovascular DiseasesCardiovascular systemChestClinicalClinical ResearchComputer softwareCustomDataDevicesDiagnosticDiastolic blood pressureDisease ManagementElectrocardiogramError SourcesEvaluationEventFreedomGoalsGuidelinesHealthcareHeartHeart RateHeightHomeHourHumanHypertensionIndividualInternationalInterventionLaboratoriesLifeMarketingMeasurementMeasuresMedicalMethodologyMethodsModalityModelingMonitorMorbidity - disease rateMovementNoiseOffice VisitsPatientsPatternPhasePhysiologic pulsePhysiologicalPolynomial ModelsPostureProtocols documentationPublic HealthReportingResearchRestSecureSleepSmall Business Innovation Research GrantSpecific qualifier valueStatistical Data InterpretationSystemTechniquesTechnologyTherapeutic InterventionTimeTrainingTubeVariantVasomotorWristarmarterial stiffnessblood pressure variabilityblood productcardiovascular disorder preventionclinical practicecloud basedcostdashboarddata qualitydesigndiagnostic valueergonomicsfoothemodynamicshuman old age (65+)hypertensiveimprovedimproved outcomeindexinginnovationinstrumentinstrumentationmortalitynext generationnovelphase 2 designspower analysispressureprognostic valueprogramsprospectiveprototyperemote gradingresearch and developmentresponsesensorsleep qualitysmart watchtelemonitoringtransmission processusabilitywhite coat hypertensionwireless
项目摘要
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.
项目概要/摘要
问题 高血压 (BP) 是一个严重的公共卫生问题,影响着 45% 的成年人(75%
65 岁以上的个体),是心血管疾病发病率和死亡率过度监测的主要原因。
作为心血管疾病的重要标志物具有很高的诊断和预后价值,
通常是在医生就诊期间通过血压测量获得的,有记录的可靠性
问题,包括“白大衣”高血压和基于听诊或示波袖带的技术不佳。
可在家庭环境中佩戴并提供定期自动测量的实验室血压监测仪 (ABPM)
超过 24 小时的时间已得到广泛采用,但这些设备的可靠性也较差。
因为即使经过培训,也很少按照指定的指南进行测量(例如,
坐着、双脚不交叉、臂带保持在心脏水平等)。
事件(可能遗漏重要的血压事件)、由于其侵入性而延长睡眠质量、混淆血压
由于袖带充气的自主反应而产生的测量结果是突兀且不舒服的。
解决方案 拟议的 BloodPressureSage(BP-SAGE)系统将是一种新颖、可靠、易于使用且易于使用的系统。
舒适(非袖带)连续 ABPM (cABPM),即使在活动期间也可以 24/7 运行
日常生活 (ADL) 和睡眠不会打扰或要求佩戴者采取任何行动,也不会强加
严格的测量准则。
这种新型血压监测仪将成为临床实践的重要补充,准确且不引人注目
评估已确诊或疑似高血压的个体,即使在运动过程中且无异常情况
舒适的袖带充气功能将提供准确的血压估计,而不会限制用户的活动能力和身体。
可以直接使用逐搏血压估计值或对任意值进行平均。
间隔(例如,重现传统的 ABPM 结果)。
第一阶段的工作将通过严格的测试来证明 BP-SAGE 方法的概念验证和可行性。
对健康和高血压受试者的评估,特别是 BP-SAGE 收缩压、舒张压和平均动脉压。
将在休息期间和不同血压水平下获得血压估计值,并与标准血压测量值进行比较
使用实验室级连续无创血压 (cNIBP) 监测仪获得的真实脉搏传导时间。
基于(PTT)的技术,并基于所提出的新颖建模方法,该方法还考虑了变化
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要求的清晰、解释性报告。
BP-SAGE 将履行国际标准并包括简化解释的摘要数据。
医疗保健和医疗保健领域需要一种符合人体工程学、准确、可靠且低成本的连续血压监测
临床研究。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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