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: 10603109
• 负责人: Mohan Thanikachalam
• 金额: $ 116.87万
• 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: 2023-01-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603109
• 关键词: Address; Ambulatory Blood Pressure Monitoring; Arteries; Black Populations; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Clinic; Clinical; Continuity of Patient Care; Contralateral; Data; Devices; Diagnosis; Early Diagnosis; European; Grant; Health; Heart; Heart Rate; Home; Hospitals; Hour; Hypertension; Hypertensive Episode; Hypotensives; Individual; Inpatients; International; Lead; Measurement; Measures; Methods; Monitor; Morbidity - disease rate; Movement; Not Hispanic or Latino; Office Visits; Operating Rooms; Outcome; Outpatients; Patients; Patients' Rooms; Pattern; Periodicals; Phase; Posture; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Prevention; Proteinuria; Protocols documentation; Randomized, Controlled Trials; Reporting; Skin; Sleep disturbances; Small Business Innovation Research Grant; Societies; Technology; Underserved Population; Validation; Visit; Woman; Wrist; accurate diagnosis; antenatal; arm; black women; blood pressure control; circadian; follow-up; hemodynamics; high risk; improved outcome; masked hypertension; meetings; mortality; patient tolerability; phase 2 study; pre-clinical; pregnancy hypertension; pressure; prevent; respiratory; risk prediction; spatiotemporal; standard measure; standard of care; usability; wearable device

Abstract: We have developed ViTrack™, a cuffless, wrist-wearable device that uses a fundamentally new method to accurately and non-invasively measure BP continuously. 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 and 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 systolic (SBP) and diastolic BPs (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 24-hour 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. Our objectives in this Phase II study are: (1) to assess the accuracy of ViTrack SBP and DBP measurements in pregnant women and as well as in women with severe preeclampsia; (2) to evaluate patient tolerance (i.e., comfort) and reliability of ViTrack’s beat-to-beat 24-hr BP measurements, and assess usability; (3) to compare the 24-hr BP profile in pregnant women with and without HDP; and (4) to compare the number of hypotensive/hypertensive episodes with ViTrack continuous measurements vs. the current standard of care of intermittent cuff measurements. The data generated will validate ViTrack as the first standalone wearable technology for accurate and continuous monitoring of BP during pregnancy.

摘要：我们已经开发了Vitrack™，这是一种无袖口的，可磨损的设备，使用了根本新的 准确和非侵入性地测量BP的方法。 Vitrack的节拍到束缚准确 测量，无论患者运动或腕部水平如何，都提供患者的昼夜节律BP 模式，包括24小时平均BP，夜间BP和BP变异性（BPV）。此外，Vitrack还测量 心率和呼吸参数和晚期血液动力学。怀孕的高血压疾病 （HDP）是发病率和死亡率的重要原因。当前测量怀孕BP的标准 妇女是振荡臂扣装置的周期性使用。振荡设备间接估计收缩期 （SBP）和舒张压（DBP）基于袖口载体期间动脉壁振荡。测量错误 继承了这种间接方法，患者姿势/运动和错误的袖口大小导致BP不可靠 50％的常规办公访问中的测量。孕妇振荡设备错误复合 由于血流动力学和血管变化减少了动脉壁的振荡，导致BP 低估。相反，这些血流动力学变化对玻璃体测量的影响较小 因为它利用压力依赖性的时空皮肤位移直接测量SBP和DBP。在 此外，在产前访问期间的随机诊所测量导致HDP的30％错误诊断 外套或掩盖高血压。另外，需要远程和连续的准确度量 BP用于预测和早日扣除先兆子痫。 24小时BP参数，例如24小时平均SBP， 夜间BP和BPV比诊所BP测量更好地预测了先兆子痫的预测指标。 Vitrack，第一个 独立的，可穿戴的，连接的设备，可以提供远程，准确的昼夜节律数据，以正确诊断 并启用预测性监视以获得更好的结果。 我们在这一第二阶段研究中的目标是：（1）评估Vitrack SBP和DBP测量的准确性 孕妇以及患有严重先兆子痫的妇女； （2）评估患者的容忍度（即 舒适性）和Vitrack的Beat-to-Beat 24小时BP测量以及评估可用性的可靠性； （3）比较 有和没有HDP的孕妇的24小时BP轮廓； （4）比较 通过Vitrack继续测量的低血压/高血压发作与当前的护理标准 间歇性袖口测量。生成的数据将验证Vitrack作为第一个独立可穿戴 在怀孕期间对BP进行准确和连续监测的技术。