ViTrack: Wearable, accurate, continuous blood pressure monitor to improve outcomes in hypertensive diseases of pregnancy

ViTrack：可穿戴、准确、连续的血压监测仪，可改善妊娠期高血压疾病的预后

• 批准号: 10851088
• 负责人: Mohan Thanikachalam
• 金额: $ 9.97万
• 依托单位: DYNOCARDIA, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10851088
• 关键词: Address; Area; Arteries; Black Populations; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Calibration; Child; Clinic; Clinical; Computer Vision Systems; Contralateral; Data; Devices; Diagnosis; Diastolic blood pressure; Early Diagnosis; Ensure; European; Grant; Health; Healthcare; Heart; Heart Rate; Hospitals; Hydrostatic Pressure; Hypertension; Hypertensive Episode; Hypotensives; Inpatients; International; Lead; Marketing; Massachusetts; Maternal Health; Measurement; Measures; Methods; Monitor; Morbidity - disease rate; Mothers; Movement; Not Hispanic or Latino; Office Visits; Outcome; Outpatients; Patients; Pattern; Periodicals; Personal Satisfaction; Phase; Positioning Attribute; Posture; Pre-Eclampsia; Pregnancy; Pregnant Women; Proteinuria; Protocols documentation; Randomized, Controlled Trials; Safety; Secure; Skin; Small Business Innovation Research Grant; Societies; Technology; Underserved Population; Universities; Validation; Visit; Woman; Wrist; antenatal; arm; blood pressure variability; circadian; effectiveness study; hemodynamics; high risk; improved outcome; masked hypertension; medical schools; mortality; phase 2 study; pre-clinical; pregnancy hypertension; pressure; respiratory; risk prediction; sensor; spatiotemporal; standard measure; standard of care; usability; wearable device

Dynocardia, a Tufts University School of Medicine and Massachusetts Institute of Technology spinoff, is addressing an unmet need for real-world accurate and continuous non-invasive blood pressure (BP) and other cardio-hemodynamic parameters. ViTrack™, a unique optomechanical sensor and computer vision technology, is the first to measure beat-to-beat systolic (SBP) and diastolic BPs (DBP) in real-world settings with the accuracy of invasive arterial pressure without external calibration, irrespective of subject movement or wrist position relative to the heart (hydrostatic pressure change). Dynocardia is expanding into the hospital market and exploring its technology's potential in other areas of healthcare, particularly in maternal health. Dynocardia has secured an SBIR Phase II grant [Project Number: 1R44HL167356-01] to study the effectiveness of ViTrack technology in ensuring the safety and well-being of mothers and their children during pregnancy. I. Project summary: ViTrack’s beat-to-beat accurate measurements, irrespective of patient movement or wrist level to the heart, provide the patient’s circadian BP pattern, including 24-hr mean BP, nighttime BP, and BP variability (BPV). In addition, ViTrack also measures heart rate, respiratory parameters, and advanced hemodynamics. The hypertensive diseases of pregnancy (HDP) are a significant cause of morbidity and mortality. The current standard for measuring BP in pregnant women is the periodic use of oscillometric arm-cuff devices. The oscillometric devices indirectly estimate SBP and DBP based on artery wall oscillations during cuff deflation. Measurement errors inherent to this indirect method, patient posture/movement, and wrong cuff size lead to unreliable BP measurements in 50% of routine office visits. Oscillometric device errors are compounded in pregnant women due to hemodynamic and vascular changes that reduce oscillations of the arterial wall, resulting in BP underestimation. In contrast, these hemodynamic changes will have less impact on ViTrack measurements because it utilizes pressure-dependent spatiotemporal skin displacement to measure SBP and DBP directly. In addition, random clinic measurements during antenatal visits lead to a 30% wrong diagnosis of HDP due to white coat or masked hypertension. In addition, there is a need for remote and continuous accurate measurement of BP for prediction and early deduction of preeclampsia. The circadian BP parameters, such as 24-hr mean SBP, nighttime BP, and BPV, are better predictors of preeclampsia than clinic BP measurements. ViTrack, the first standalone, wearable, connected device, can provide remote, accurate circadian BP data for correct diagnosis and enable predictive monitoring for better outcomes. In preclinical, outpatient [vs. auscultatory method], and inpatient [vs. invasive arterial pressure], ViTrack met FDA standards for accuracy. In this SBIR Phase II study, we are expanding the application of ViTrack in HDP in partnership with NYC Health + Hospitals that serves underserved populations, a large percentage of them non-Hispanic Black population at high risk for HDP. The Aims of the study are: Specific Aim (SA) 1: Assess the accuracy of ViTrack BP measurements (n=48). SA1(a): Determine the accuracy of ViTrack measurements in pregnant women (n=33) as per the European Society of Hypertension International Protocol-2010) [34]; SA1(b): Determine accuracy in severe preeclampsia (n=15), defined as BP measurement of 170/110 or more and proteinuria of 500 mg or more in 24-hr. Milestone: ViTrack accurately measures BP in pregnant women, including women with severe preeclampsia. SA2: Assessment of 24-hr BP with ViTrack (n=100). Collect 24-hr BP with ViTrack and intermittent cuff BP measurements as per standard practice from the contralateral arm; SA2(a): Assess tolerability/usability and reliability of 24-hr beat-to-beat BP in unconstrained subjects (n=20); SA2(b): Compare the 24-hr BP profile in pregnant women with and without HDP (n=80); SA2(c): Compare the number of hypotensive/hypertensive episodes with ViTrack continuous measurements vs. the intermittent cuff measurements. Milestone: ViTrack provides reliable 24-hr data despite patient movement. The data generated will validate ViTrack as the first standalone technology for accurate and continuous BP during pregnancy. This foundational data will inform the commercial build, final clinical validation and FDA submission, and 510(k) approval for continuous BP measurement in pregnant women. In addition, further randomized control trials will validate the application of ViTrack in risk prediction, early diagnosis, and management of preeclampsia and, thus, as the new standard of care for BP monitoring during pregnancy.

心动过速是塔夫茨大学医学院和马萨诸塞州理工学院的一个分支， 解决了对真实世界的准确和连续的非侵入性血压（BP）和其他血压测量的未满足的需求， 心脏血流动力学参数。ViTrack™，独特的光学机械传感器和计算机视觉 技术，是第一个在现实环境中测量心跳收缩压（SBP）和舒张压（DBP）的技术 具有无外部校准的有创动脉压的准确性，无论受试者移动或 手腕相对于心脏的位置（流体静压变化）。心动过速正在向医院扩展 市场和探索其技术在其他医疗保健领域的潜力，特别是在孕产妇保健领域。 Dynocardia已获得SBIR II期资助[项目编号：1 R44 HL 167356 -01]，用于研究 ViTrack技术在确保母婴安全和福祉方面的有效性 怀孕 I.项目概要： ViTrack的逐搏精确测量，无论患者移动或手腕与心脏的水平如何， 提供患者的昼夜血压模式，包括24小时平均血压、夜间血压和血压变异性（BPV）。在 此外，ViTrack还可测量心率、呼吸参数和高级血液动力学。的 妊娠期高血压疾病（HDP）是发病率和死亡率的重要原因。当前 测量孕妇血压的标准是定期使用血压计臂袖装置。的 血压计装置基于袖带放气期间的动脉壁振荡间接估计SBP和DBP。 这种间接方法固有的测量误差、患者姿势/运动和错误的袖带尺寸导致 在50%的日常办公室访视中，血压测量结果不可靠。振荡器装置误差在以下情况下是复杂的： 孕妇由于血液动力学和血管变化减少了动脉壁的振荡， BP被低估。 相比之下，这些血流动力学变化对ViTrack测量的影响较小，因为它利用了 压力依赖性时空皮肤位移直接测量SBP和DBP。此外，随机 产前检查期间的临床测量导致30%的HDP误诊，原因是白色被毛或 掩盖性高血压此外，需要远程和连续精确测量BP， 先兆子痫的预测和早期推断。昼夜血压参数，如24小时平均SBP， 夜间血压和BPV比临床血压测量更能预测先兆子痫。ViTrack，第一个 独立的、可穿戴的、连接的设备，可以提供远程的、准确的昼夜血压数据，以进行正确的诊断 并实现预测性监测以获得更好的结果。 在临床前、门诊患者[与听诊方法]和住院患者[与有创动脉压]中，ViTrack符合 FDA标准的准确性。在这项SBIR第二阶段研究中，我们正在扩展ViTrack在HDP中的应用 与纽约市健康+医院合作，为服务不足的人群提供服务，其中很大一部分人 非西班牙裔黑人人群HDP的高风险。研究的目的是： 特定目标（SA）1：评估ViTrack BP测量的准确性（n=48）。SA 1（a）：确定 根据欧洲高血压学会，孕妇（n=33）中ViTrack测量的准确性 国际方案-2010）[34]; SA 1（B）：确定重度先兆子痫（n=15）的准确性，定义为BP 在24小时内测量170/110或更高，蛋白尿500 mg或更高。里程碑：ViTrack准确 测量孕妇的血压，包括患有严重先兆子痫的妇女。 SA 2：使用ViTrack评估24小时BP（n=100）。使用ViTrack和间歇袖带BP采集24小时BP 根据对侧组的标准实践进行测量; SA 2（a）：评估耐受性/可用性， 不受限受试者（n=20）24小时逐搏BP的可靠性; SA 2（B）：比较 有和没有HDP的孕妇（n=80）; SA 2（c）：比较水肿/高血压的数量 ViTrack连续测量与间歇袖带测量的发作。里程碑：ViTrack 提供可靠的24小时数据，尽管患者移动。 生成的数据将验证ViTrack作为第一个独立技术的准确和连续的BP 孕期这些基础数据将为商业构建、最终临床确认和FDA提供信息 提交和510（k）批准用于妊娠女性的连续BP测量。此外，进一步 随机对照试验将验证ViTrack在风险预测、早期诊断和 管理先兆子痫，因此，作为妊娠期间血压监测的新护理标准。