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：
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
项目类别：
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&apos 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

项目摘要

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：我们开发了 ViTrack™，这是一种无袖带、腕部可穿戴设备，采用全新技术 ViTrack 连续准确、无创测量血压的方法。无论患者的运动或手腕与心脏的高度如何，测量结果都可以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。心率和呼吸参数以及妊娠期高血压疾病。 (HDP) 是妊娠期血压测量的重要原因。女性定期使用示波臂袖装置示波装置间接估计收缩压。 (SBP) 和舒张压 (DBP) 基于袖带放气期间的动脉壁振荡测量误差。这种间接方法固有的、患者姿势/运动以及错误的袖带尺寸会导致血压不可靠 50% 的常规办公室就诊中的测量结果在孕妇中更为复杂。由于血流动力学和血管变化减少了动脉壁的振荡，从而导致血压相比之下，这些血流动力学变化对 ViTrack 测量的影响较小。因为它利用压力依赖性时空皮肤位移来直接测量收缩压和舒张压。此外，产前检查测量过程中的随机临床检查会导致 30% 的 HDP 诊断错误，原因是白种人此外，还需要对隐匿性高血压进行远程、连续的精确测量。用于预测和早期推断先兆子痫的血压 24 小时血压参数，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。我们第二阶段研究的目标是：(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女性；（2）评估患者的耐受性（即， (3)比较患有和不患有 HDP 的孕妇的 24 小时血压概况；以及 (4) 比较发生 HDP 的人数； ViTrack 连续测量的低血压/高血压发作与当前护理标准的比较生成的数据将验证 ViTrack 是第一个独立的可穿戴设备。准确、连续监测妊娠期间血压的技术。