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

摘要：我们已经开发了ViTrack™，这是一款无袖口、可戴在手腕上的设备，它使用了全新的 方法准确、无创地连续测量血压。ViTrack的节拍精准 无论患者的运动或手腕与心脏的水平如何，测量结果都能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高级血流动力学。妊娠高血压疾病 (HDP)是发病率和死亡率的一个重要原因。现行孕妇血压测量标准 女性则是定期使用示波式袖带装置。示波测量装置间接估计心脏收缩压 (SBP)和舒张压(DBP)，基于袖带放气时的动脉壁振荡。测量误差 这种间接方法固有的患者姿势/运动和错误的袖带大小会导致不可靠的BP 在50%的例行办公室访问中进行测量。在孕妇中，示波测量装置的错误是复杂的 由于血液动力学和血管变化减少了动脉壁的振荡，导致BP 低估了。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的时空皮肤位移来直接测量SBP和DBP。在……里面 此外，在产前就诊期间的随机临床测量导致30%的HDP错误诊断是由于白人 外衣或伪装的高血压。此外，还需要远程和连续的准确测量 BP用于预测和早期推断子痫前期。24小时血压参数，如24小时平均SBP， 夜间血压和BPV是先兆子痫的更好的预测指标，而不是临床血压测量。ViTrack，第一个 独立的、可穿戴的、联网的设备，可以提供远程、准确的昼夜血压数据，以便正确诊断 并启用预测性监测，以获得更好的结果。 我们在此第二阶段研究中的目标是：(1)评估ViTrack SBP和DBP测量的准确性 孕妇以及患有严重子痫前期的妇女；(2)评估患者的耐受性(即， 舒适度)和ViTrack的24小时BP测量的可靠性，并评估可用性；(3)比较 有无HDP孕妇的24小时血压曲线；和(4)比较 使用ViTrack连续测量的低血压/高血压发作与当前护理标准的比较 断断续续的袖口测量。生成的数据将验证ViTrack是第一款独立可穿戴设备 准确、连续监测孕期血压的技术。

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.