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

基本信息

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
项目类别：
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

项目摘要

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.

Dynocardia 是塔夫茨大学医学院和麻省理工学院的附属机构，解决现实世界对准确、连续的无创血压 (BP) 和其他数据的未满足的需求 ViTrack™，一种独特的光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逐次收缩压 (SBP) 和舒张压 (DBP) 的技术具有有创动脉压的准确性，无需外部校准，无论受试者运动或手腕与心脏的相对位置（静水压变化）正在扩展到医院。市场并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方面。 Dynocardia 已获得 SBIR 第二阶段拨款 [项目编号：1R44HL167356-01] 以研究 ViTrack 技术在确保母亲及其孩子的安全和福祉方面的有效性怀孕。一、项目概要： ViTrack 的逐搏准确测量，无论患者运动或手腕与心脏的高度无关，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)。此外，ViTrack 还可以测量心率、呼吸参数和高级血流动力学。妊娠高血压疾病（HDP）是发病率和死亡率的重要原因。测量孕妇血压的标准是定期使用示波臂带装置。示波设备根据袖带放气期间动脉壁的振荡间接估计收缩压和舒张压。这种间接方法固有的测量误差、患者姿势/运动以及错误的袖带尺寸会导致 50% 的日常就诊中血压测量结果不可靠，示波测量设备的错误更加严重。孕妇由于血流动力学和血管的变化减少了动脉壁的振荡，导致血压低估。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由于白大衣或此外，还需要远程连续准确测量血压。先兆子痫的预测和早期推断。昼夜节律血压参数，例如 24 小时平均收缩压，夜间血压和 BPV 是比第一个诊所血压测量更好的先兆子痫预测指标。独立、可穿戴、连接的设备，可以提供远程、准确的昼夜血压数据以进行正确的诊断并实现预测性监控以获得更好的结果。在临床前、门诊[与听诊法]和住院[与有创动脉压]中，ViTrack 均达到要求 FDA 的准确性标准。在这项 SBIR II 期研究中，我们正在扩大 ViTrack 在 HDP 中的应用。与 NYC Health + Hospitals 合作，为服务不足的人群（其中很大一部分）提供服务 HDP 高风险的非西班牙裔黑人该研究的目的是：具体目标 (SA) 1：评估 ViTrack BP 测量的准确性 (n=48)：确定 SA1(a)。根据欧洲高血压学会的规定，孕妇 (n=33) ViTrack 测量的准确性 International Protocol-2010) [34]；SA1(b)：确定严重先兆子痫 (n=15) 的准确性，定义为 BP 24 小时内测量值达到 170/110 或以上，蛋白尿达到 500 毫克或以上。里程碑：ViTrack 准确。测量孕妇（包括患有严重先兆子痫的女性）的血压。 SA2：使用 ViTrack 评估 24 小时血压（n=100）使用 ViTrack 和间歇袖带血压收集 24 小时血压。根据对侧手臂的标准做法进行测量；SA2(a)：评估耐受性/可用性和不受约束的受试者中 24 小时逐搏血压的可靠性 (n=20)；SA2(b)：比较 24 小时血压曲线患有和不患有 HDP 的孕妇 (n=80)；SA2(c)：比较低血压/高血压的数量 ViTrack 连续测量与间歇性袖带测量的对比：里程碑：ViTrack 尽管患者移动，仍可提供可靠的 24 小时数据。生成的数据将验证 ViTrack 是第一个实现准确、连续血压的独立技术该基础数据将为商业构建、最终临床验证和 FDA 提供信息。提交，以及 510(k) 批准对孕妇进行连续血压测量。随机对照试验将验证 ViTrack 在风险预测、早期诊断和治疗方面的应用先兆子痫的管理，因此成为妊娠期间血压监测的新护理标准。