Continuous Non-Invasive Blood Pressure Monitor for Neonates

新生儿连续无创血压监测仪

• 批准号: 9910153
• 负责人: Xina Quan
• 金额: $ 22.46万
• 依托单位: PYRAMES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-06 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9910153
• 关键词: Academic Medical Centers; Accounting; Adult; Antihypertensive Agents; Area; Arterial Lines; Birth; Blood Pressure; Blood Pressure Monitors; Blood pressure determination; Bluetooth; Calibration; Cells; Child; Childhood; Clinical; Clinical Data; Clinical Research; Coin; Computer Analysis; Computer software; Consumption; Critical Illness; Data; Data Analytics; Databases; Development; Device Designs; Devices; Disadvantaged; Electromagnetics; Electronics; Female; Film; Goals; Gold; Heart Rate; Hemorrhage; Infant; Institutional Review Boards; Lead; Limb structure; Machine Learning; Measurement; Measures; Medical Staff; Methods; Modeling; Modification; Monitor; Morbidity - disease rate; Morphologic artifacts; Neonatal; Neonatal Intensive Care Units; Nerve; Neural Network Simulation; Noise; Pain; Paper; Patients; Phase; Photoplethysmography; Physiologic pulse; Polychlorinated Biphenyls; Positioning Attribute; Process; Production; Pulse Pressure; Reading; Records; Resolution; Risk; Signal Transduction; Skin; Surface; System; Technology; Testing; Thick; Thinness; Time; Tissues; Training; Wireless Technology; Work; Wrist; artificial neural network; base; care costs; cost; cost effective; demographics; design; encryption; flexibility; follow-up; improved; infection risk; light weight; male; miniaturize; neonate; neural network; novel; pressure; preterm newborn; scale up; sensor; sensor technology; skills; success; tonometry

Summary/Abstract Each year, about 5-18% of babies are born preterm, accounting for over 0.5M births in the US and 15M globally. Many of these babies are admitted to Neonatal Intensive Care Units (NICUs) where the medical staff generally have the option of using either invasive arterial lines (IALs) or inflatable-cuff non-invasive blood pressure (NIBP) monitoring. The former introduces the risk of infection, tissue and nerve damage, and the latter is less accurate, especially for hypotensive infants, and may add the risk of ischemic and nerve damage upon repeated measurement. There is a clear need for a safer, continuous, and cost effective form of NIBP measurement to meet the challenge of managing unhealthy blood pressures for neonates. PyrAmes Inc. has developed a novel capacitive sensor technology that is paper thin and flexible and can accurately detect blood pressure (BP). This sensor technology is part of a unique continuous BP monitoring platform that provides accurate, lightweight and comfortable BP monitoring in a wireless, wrist-worn package that is easy to use. The system uses lightweight neural networks to analyze pulse waveform data to provide continuous determination of systolic, diastolic, and mean BP, heart rate, and their variabilities. The sensor is easy to apply non-invasively and records pulsatile data similar to an arterial line, while avoiding the difficulties of placing and maintaining an arterial line. This device can provide gold standard BP monitoring without perturbing the patients for more accurate and relevant measurements. The objective of this project is to extend the platform for use with term and pre-term neonates. This goal will be accomplished through redesign of the sensor hardware and optimization of the data analytics software. We will validate these modifications with clinical data from the NICU at Stanford University Medical Center. In Phase I, we will miniaturize the electronics and modify the sensor array of a wrist-worn pulse wave monitor to be sized more appropriately for neonates. We will validate the new device design by collecting NICU clinical data from patients who have IALs in place in an IRB-approved study. From IAL and sensor data taken simultaneously, we will determine ground truth values on a pulse-by-pulse basis and use these data in conjunction with additional IAL data from historical databases to improve our sensor quality and predictive BP models. Our success metric will be to equal or exceed the quality and accuracy of our data for adults. Phase II will be a follow-up IRB-approved pivotal study using the device from Phase 1 to position our device for FDA submission and clearance and scale up to pilot production of this device.

摘要/摘要 每年，大约5-18％的婴儿出生的早产，在美国占了超过1500万的出生时间 全球。这些婴儿中有许多被接纳为新生儿重症监护病房（NICUS） 通常可以选择使用侵入性动脉线（ILS）或充气-Cuff非侵入性血液 压力（NIBP）监测。前者引入了感染，组织和神经损伤的风险，以及 后者的准确性较差，尤其是对于降压婴儿，可能会增加缺血和神经损伤的风险 重复测量后。显然需要一种更安全，连续且具有成本效益的NIBP形式 衡量应对新生儿不健康的血压的挑战。 Pyrames Inc.开发了一种新型的电容传感器技术，该技术是纸薄且灵活的，可以 准确检测血压（BP）。该传感器技术是独特的连续BP监控的一部分 在无线腕带包装中提供准确，轻巧且舒适的BP监视的平台 这很容易使用。该系统使用轻型神经网络分析脉冲波形数据以提供 连续确定收缩期，舒张压和平均BP，心率及其变异性。传感器是 易于非侵入性应用，记录与动脉线相似的脉动数据，同时避免了困难 放置和维持动脉线。该设备可以提供黄金标准的BP监控，而无需 扰动患者进行更准确和相关的测量。 该项目的目的是扩展与期限和术前新生儿一起使用的平台。这个目标将是 通过重新设计传感器硬件和数据分析软件的优化来完成。我们 将通过斯坦福大学医学中心的NICU临床数据来验证这些修改。 在第一阶段，我们将微型化电子设备并修改腕部脉动波监视器的传感器阵列 对于新生儿，更适合尺寸。我们将通过收集NICU临床来验证新设备设计 来自IRB批准的研究中有IAL的患者的数据。从ial和传感器数据中 同时，我们将根据脉冲确定地面真实价值，并在 与历史数据库中的其他IAL数据结合，以提高我们的传感器质量和预测BP 型号。我们的成功指标将等于或超过成人数据的质量和准确性。 第二阶段将是IRB批准的后续研究的关键研究，使用该设备从第1阶 FDA提交和许可并扩展到该设备的试点生产。

项目成果

Advances in Non-Invasive Blood Pressure Monitoring.

• DOI: 10.3390/s21134273
• 发表时间: 2021-06-22
• 期刊: Sensors (Basel, Switzerland)
• 作者: Quan X;Liu J;Roxlo T;Siddharth S;Leong W;Muir A;Cheong SM;Rao A
• 通讯作者: Rao A

Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates.

• DOI: 10.3390/s23073690
• 发表时间: 2023-04-02
• 期刊: Sensors (Basel, Switzerland)
• 作者: Rao A;Eskandar-Afshari F;Weiner Y;Billman E;McMillin A;Sella N;Roxlo T;Liu J;Leong W;Helfenbein E;Walendowski A;Muir A;Joseph A;Verma A;Ramamoorthy C;Honkanen A;Green G;Drake K;Govindan RB;Rhine W;Quan X
• 通讯作者: Quan X