Remote and non-invasive continuous cardiopulmonary monitoring using low-power FM

描述（由申请人提供）： 提议的研究。系统微技术公司（SMT）提出研究的可行性，并建立一种新的基于雷达的监测早期检测心肺骤停（CA）的机制，通过显示SMT的微功率调频雷达（MFMR）可以检测以下四个生理变量的变化：心率，呼吸频率，心输出量和呼吸潮气量。MFMR旨在远程、非侵入性地连续监测这些变量，对患者没有健康风险。 问题/机会。在美国，心脏骤停（CA）是院内死亡的主要近因，通常可以通过适当的干预来逆转或预防;然而，为了有效，挽救生命的活动必须在CA后几分钟内开始。可以降低CA死亡率的两个关键参数是扩大连续监测CA体征的患者数量，并通过跟踪更多的生理变量来提高监测的可靠性。SMT提出的基于MFMR的创新型监测器可以通过连续远程和非接触式检测患者心脏和呼吸活动的速率和输出量的变化来实现这两种效果。MFMR的便利性和低运营成本将允许显著扩展接受连续心肺监测的患者的类型和数量。 项目大纲。SMT将使用其现有的MFMR单元（为非医疗目的开发）作为起点来构建原型雷达监视器。新的原型将进行校准和一系列性能测试。一旦准备就绪，原型将用于验证四个感兴趣的生理变量的测量：心率（HR）呼吸率（RR）的绝对值以及心脏射血分数（EF）和呼吸潮气量（Vt）的相对变化。将开发数据处理和分析算法，从雷达反射模式中提取这些参数的值。将使用Jaszczak跳动心脏体模实验对HR和EF监测进行确认。将通过加州太平洋医学中心的患者研究对HR和RR的同时测量以及Vt变化的检测进行验证。定义了测量这些参数中每一个的定量里程碑。必须达到根据这些里程碑制定的成功标准，才能进入项目的第二阶段。 效益如果CA检测的可行性得到证实，SMT将着手开发一种可销售的心肺监测设备，供医院和家庭使用。该器械将自动记录数据，并将其传送到医院患者警报以及通信系统，以进行进一步评估。当与其他方法同时使用时，监护仪将作为诊断信息的单一来源或作为综合患者评价的组成部分之一。所提出的方法引入了主要的创新，带来了三个关键的好处：SMT雷达的非接触和方便的性质使其（1）显着扩大监测患者的数量，（2）减少护理人员花费的时间;（3）SMT的雷达可以检测心输出量和呼吸潮气量的变化，这两个重要的变量现在不常监测。这种新的诊断信息可以更好地理解导致CA的生理病理学。 公共卫生相关性： 可靠和方便的连续心肺监测方法的可用性对于预防心脏骤停死亡率至关重要。预警信号的早期检测可以预防许多高危患者的心肺骤停死亡，无论是在重症监护环境中，还是在普通医院病房或家中。作为拟议研究的结果而开发的远程非接触式监测技术将在心肺监测中引入新的范例，可能降低心肺骤停患者的死亡率并提高患者的舒适度，同时甚至可能降低护理成本。

DESCRIPTION (provided by applicant): Proposed Research. Systems Micro Technologies (SMT) proposes to research the feasibility and to establish the mechanisms of applying a novel radar-based monitor for early detection of cardiopulmonary arrest (CA) by showing that SMT's micropower frequency-modulated radar (MFMR) can detect changes in the following four physiological variables: heart rate, respiratory rate, cardiac output and respiratory tidal volume. MFMR aims to enable continuous monitoring of these variables remotely, non-invasively and with no health risks to the patients. Problem/Opportunity. Cardiopulmonary arrest (CA), the leading proximate cause of in- hospital death in the US, can often be reversed or prevented with adequate intervention; however, in order to be effective, the life-saving activities have to start within minutes after CA. Two critical parameters that can reduce CA-mortality are expansion of the number of patients continuously monitored for the signs of CA and improving the reliability of monitoring by tracing more physiological variables. The innovative MFMR-based monitor proposed by SMT can achieve both of these effects by continuous remote and non-contact detection of changes in both the rates and output volumes of cardiac and respiratory activity of patients. MFMR's convenience and low operational cost will allow significant expansion of the types and numbers of patients subjected to continuous cardiopulmonary monitoring. Project Outline. SMT will build a prototype radar monitor using its currently existing MFMR unit (developed for non-medical purposes) as a starting point. The new prototype will be calibrated and undergo a series of performance tests. Once ready, the prototype will be used to validate the measurement of the four physiological variables of interest: absolute values of heart rate (HR) respiration rate (RR) and relative changes in cardiac ejection fraction (EF) and respiration tidal volume (Vt). Data processing and analysis algorithms will be developed to extract the values of these parameters from the radar reflection patterns. HR and EF monitoring will be validated using the Jaszczak beating heart phantom experiments. Simultaneous measurements of HR and RR, and detection of changes in Vt will be validated via patient studies at California Pacific Medical Center. Quantitative milestones for measurement of each of these parameters are defined. Success criteria formulated in terms of these milestones will have to be met in order to move to Phase 2 of the project. Benefits. If the feasibility for CA detection is confirmed, SMT will proceed to developing a marketable cardiopulmonary monitoring device for hospital and in-home use. The device will record data automatically and communicate it to the hospital patient alarm as well as communication system for further evaluation. The monitor will be used either as a single source of diagnostic information or as one of the components in a comprehensive patient evaluation when used in parallel with other methods. The proposed approach introduces major innovations that lead to three key benefits: The non-contact and convenient nature of SMT's radar allows it (1) to significantly expand the number of monitored patients, and (2) to reduce the time spent by caregivers; (3) SMT's radar can detect changes in cardiac output and respiration tidal volume, two important variables that are not commonly monitored now. This new diagnostic information can enable better understanding of the physiopathologies leading to CA. PUBLIC HEALTH RELEVANCE: Availability of reliable and convenient methods of continuous cardiopulmonary monitoring is critical for prevention of cardiac arrest mortality. Early detection of warning signs can prevent cardiopulmonary arrest deaths in many at-risk patients, both in the intensive care environment, in general hospital wards or at home. Remote, non-contact monitoring technology developed as the result of the proposed research will introduce a new paradigm in cardiopulmonary monitoring, potentially reducing the patient mortality from cardiopulmonary arrest and improving the patient's comfort while potentially even decreasing the cost of care.