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.

翻译后摘要：我们已经开发了ViTrack™，一个袖口，手腕可穿戴设备，使用一个全新的 一种准确、无创地连续测量BP的方法。ViTrack的逐拍精确 测量，无论患者的运动或手腕水平的心脏，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还测量 心率和呼吸参数以及先进的血液动力学。妊娠期高血压疾病 (HDP)是发病率和死亡率的重要原因。孕妇血压测量的现行标准 妇女是周期性使用的测量臂袖口装置。血压测量装置间接估计收缩压 (SBP)和基于袖带放气期间动脉壁振荡的舒张压（DBP）。测量误差 这种间接方法固有的问题是，患者姿势/运动和错误的袖带尺寸会导致不可靠的BP 在50%的例行办公室访问中进行测量。振荡器装置误差在孕妇中是复杂的 由于血液动力学和血管变化减少了动脉壁的振荡，导致BP 低估相比之下，这些血流动力学变化对ViTrack测量的影响较小 因为它利用压力相关的时空皮肤位移直接测量SBP和DBP。在 此外，在产前检查期间的随机临床测量导致30%的HDP误诊，由于白色， 被膜或被掩盖的高血压此外，还需要远程和连续精确测量 BP用于先兆子痫的预测和早期推断。24小时BP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。 我们在这项II期研究中的目标是：（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）评价患者耐受性（即， 舒适度）和ViTrack的逐搏24小时BP测量的可靠性，并评估可用性;（3）比较 有和没有HDP的孕妇的24小时血压曲线;（4）比较 ViTrack连续测量的水肿/高血压发作与当前标准治疗 间歇性袖带测量。生成的数据将验证ViTrack作为第一个独立的可穿戴设备 在怀孕期间准确和连续监测血压的技术。