Development of a blood pressure monitoring system based on smart-camera video recording

基于智能摄像头录像的血压监测系统的研制

• 批准号: 10255894
• 负责人: Craig White
• 金额: $ 23.77万
• 依托单位: OVID BP SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-15 至 2022-04-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10255894
• 关键词: Adult; Affect; Age; Aging; Algorithms; Ambulatory Blood Pressure Monitoring; Archives; Area; Back; Biological Markers; Blood; Blood Pressure; Blood Pressure Monitors; Blood flow; Brain; Brain hemorrhage; Businesses; Calibration; Cardiology; Cellular Phone; Cessation of life; Child; Clinical; Clinical Data; Collaborations; Computer software; Congestive Heart Failure; Coronary; Data; Dermatologic; Detection; Development; Devices; Diabetes Mellitus; Diagnosis; Dialysis procedure; Diastolic blood pressure; Diffusion; Discipline; Early Intervention; Engineering; Enrollment; Equipment; European; Exhibits; FDA approved; Face; Fingers; Gold; Head Movements; Health Personnel; Heart; Heart Rate; Hemorrhage; Home; Human; Human Resources; Hypertension; Individual; Information Systems; Intervention; Ischemic Stroke; Kidney; Kidney Failure; Legal patent; Masks; Measurement; Measures; Medical; Medical Device; Medicine; Mercury; Methods; Michigan; Modernization; Monitor; Patients; Performance; Phase; Physiologic pulse; Plethysmography; Population; Positioning Attribute; Protocols documentation; Public Health; Reading; Risk Factors; Role; Secure; Series; Signal Transduction; Skin; Skin Aging; Societies; Sphygmomanometers; Study Subject; Sunscreening Agents; Symptoms; System; Tablets; Technology; Therapeutic; Time; Training; United States; Validation; Variant; Video Recording; Visual impairment; Work; Wrist; accurate diagnosis; base; blood flow measurement; blood pressure regulation; cloud based; cloud storage; comorbidity; cost; disability-adjusted life years; empowered; human old age (65+); human study; human subject; in vivo evaluation; innovative technologies; loss of function; novel strategies; ovid; phase 1 study; portability; prevent; sex; skin color; smartphone Application; software development; white coat hypertension

PROJECT SUMMARY Hypertension causes 7.5 M deaths worldwide with no warning signs or symptoms and occurs in more than two thirds of individuals over the age of 65. Hypertension represents a major risk factor for coronary heart problems including ischemic and hemorrhagic strokes, kidneys failure, and visual impairment. The most impactful action against hypertension is represented by frequent blood pressure (BP) measurements, which assure early intervention and its successful management. BP monitoring occurs mainly at the Health Care Provider’s (HCP) office through cuff-based devices (e.g. sphygmomanometer) that can only accurately be operated by trained personnel. Moreover, clinical BP measurement has the potential to cause Masked and White Coat Hypertension, two well-known phenomena that prevent correct BP assessment and assignment of a proper therapeutic plan in nearly 40% of the patients. Other alternatives are represented by ambulatory BP monitoring (ABPM) and home blood pressure measurement (HBPM) devices which have shown limitations due to costs, practicality, and inaccuracy. Ovid BP proposes an innovative technology to allow comprehensive BP detection and management via patented software that leverages today’s advanced smartphone camera technology to capture the biomarkers required to determine a patients’ BP. The solution is empowered by an algorithm that estimates BP from the heart’s QRS signal, which is specifically captured through analysis of the patients’ Vertical Head Movement (VHM). Additionally, the rate of facial blood flow is observed through the well-understood practice of video plethysmography (vPPG). With this data the system is capable of producing the Instantaneous Hearth Rate Period (THRi) and Instantaneous Pulse Transit Time (PTTi), which are analyzed by a cloud-based algorithm yielding systolic and diastolic blood pressure as well as heart rate in a matter of moments. Ovid’s technology has been tested in-vivo against clinical-grade HBPM devices and has exhibited a strong correlation to the reference measurements obtained by the modern standard. In this Phase I application, Ovid BP will assess the feasibility of the proposed approach to correctly detect BP when confronted with variables that might affect vPPG and QRS estimation. Specific activities will include a study on selected human subjects to validate the technology against a mercury sphygmomanometer and to investigate the role of age, sex, skin tone, and BP baseline as the cause of errors. Data collected will be used to perform algorithm refinements required to solve any issues associated with these variables. The conclusion of the proposed Phase I study will establish the feasibility of Ovid BP’s video-based approach to measuring BP. During Phase II, Ovid will conduct a larger study to identify and solve other key issues affecting the readings, including potential dermatological conditions that may impede the accurate assessment of both VHM and PPG.

项目概要 高血压导致全球 750 万人在没有任何警告信号或症状的情况下死亡，并且发生在超过 2 个国家 三分之一的人年龄超过 65 岁。高血压是冠心病的主要危险因素 包括缺血性和出血性中风、肾衰竭和视力障碍。 预防高血压的方法是频繁测量血压（BP），这可以确保及早发现 干预及其成功管理主要发生在医疗保健提供者 (HCP) 处。 通过基于袖带的设备（例如血压计）进行办公室办公，这些设备只能由经过培训的人员准确操作 此外，临床血压测量有可能导致蒙面高血压和白大衣高血压。 两个众所周知的现象阻碍了正确的血压评估和指定适当的治疗计划 近 40% 的患者采用动态血压监测 (ABPM) 和家庭监测作为其他选择。 由于成本、实用性和安全性等原因，血压测量 (HBPM) 设备已显示出局限性 Ovid BP 提出了一种创新技术来实现全面的 BP 检测和管理。 通过专利软件，利用当今先进的智能手机摄像头技术来捕捉 确定患者血压所需的生物标志物 该解决方案由估计血压的算法提供支持。 来自心脏的 QRS 信号，该信号是通过分析患者的垂直头专门捕获的 此外，通过众所周知的实践来观察面部血流量。 借助视频体积描记法 (vPPG)，系统能够生成瞬时炉膛数据。 速率周期 (THRi) 和瞬时脉冲传输时间 (PTTi)，通过基于云的算法进行分析 奥维德的技术可以在短时间内产生收缩压和舒张压以及心率。 已针对临床级 HBPM 设备进行了体内测试，并显示出与参考的强相关性 在此第一阶段的应用中，Ovid BP 将评估按照现代标准获得的测量结果的可行性。 当遇到可能影响 vPPG 和 QRS 的变量时，正确检测 BP 的提议方法 具体活动将包括对选定的人类受试者进行研究，以验证该技术。 水银血压计，并调查年龄、性别、肤色和血​​压基线作为原因的作用 收集的数据将用于执行解决任何相关问题所需的算法改进。 拟议的第一阶段研究的结论将确定 Ovid BP 的可行性。 在第二阶段，奥维德将进行一项更大规模的研究来识别和解决基于视频的血压测量方法。 影响读数的其他关键问题，包括可能妨碍读数的潜在皮肤病状况 VHM 和 PPG 的准确评估。