A Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients

描述（由申请人提供）：心输出量（CO）监测可以通过早期发现和诊断疾病以及目标导向治疗来改善危重患者的结局。然而，由于其侵入性，CO监测急剧下降。Retia Medical将提供一种设备，通过对许多患者已经测量的微创和非侵入性生理波形进行数学分析来计算CO。Retia广泛研究的“脉搏轮廓分析”解释了迄今为止被竞争分析忽略的生理学的关键方面，以在血流动力学不稳定期间提供上级准确性。这个SBIR项目的总体目标是建立一个原型设备， Retia的脉搏轮廓实时分析，并验证设备是否符合FDA要求。该器械必须能够处理由患者移动、传感器断开和各种其他来源引起的危重患者生理波形中的频繁伪影。然而，自动处理这样的工件已被证明是不平凡的。因此，该I期项目的具体目标是：（1）开发用于自动检测波形伪影的前端算法，以及（2）验证受真实世界伪影污染的患者波形上的算法。将开发一种算法，根据波形的已知属性及其相互关系自动检测难以处理的伪影。（在这种伪影期间，Retia的设备不会输出任何CO估计值，而不是提供潜在的误导性估计值。）该算法将应用于现有的波形数据库，用于分析危重患者在正常护理期间的波形。算法的准确性将根据由经验丰富的护理人员通过目视检查波形独立确定的伪影进行评估。这个有效的第一阶段项目的里程碑是算法在检测波形中的伪影时达到90%的灵敏度和特异性。在实现这一里程碑之后，将进行一个简单的第二阶段项目，将Retia的伪影检测算法和脉搏轮廓分析纳入一个基于PC的系统中，该系统配有一次性传感器，并对该设备的安全性和准确性进行前瞻性测试。最终，Retia的设备可能有助于改善重症患者的预后。 公共卫生相关性：血流量可以指导护理人员治疗生病的病人，但目前还没有很好的方法来测量它。Retia Medical将为生病的病人开发一种有效的无创血流量监测仪，易于使用，准确，并根据FDA的要求验证该设备。

DESCRIPTION (provided by applicant): Cardiac output (CO) monitoring can improve the outcomes of critically ill patients via early detection and diagnosis of disease and goal-directed therapy. Yet, CO monitoring has sharply declined due to its invasiveness. Retia Medical will offer a device that computes CO by mathematical analysis of minimally invasive and non-invasive physiologic waveforms that are already being measured in many patients. Retia's extensively investigated "pulse contour analysis" accounts for crucial facets of the physiology ignored hitherto by competing analyses to afford superior accuracy during hemodynamic instability. The overall objective of this SBIR project is to build a prototype device to implement Retia's pulse contour analysis in real-time and to verify the device according to FDA requirements. This device must be able to deal with the frequent artifact in physiologic waveforms from critically ill patients caused by patient movement, sensor disconnections, and a variety of other sources. However, automatic handling of such artifact has proven non-trivial. Hence, the specific aims of this Phase I project are: (1) to develop a front-end algorithm for automatic detection of waveform artifact and (2) to verify the algorithm on patient waveforms contaminated with real-world artifact. An algorithm will be developed that automatically detects intractable artifact based on the known attributes of the waveforms as well as their inter-relationships. (During such artifact, Retia's device will not output any CO estimate rather than provide a potentially misleading one.) The algorithm will be applied to an available database of the waveforms for analysis from critically ill patients during their normal care. The accuracy of the algorithm will be assessed against artifact independently ascertained via visual inspection of the waveforms by an experienced caregiver. The milestone of this efficient Phase I project is for the algorithm to attain ¿90% sensitivity and specificity in detecting artifact in the waveforms. Achievement of this milestone will be followed by a straightforward Phase II project to incorporate Retia's artifact detection algorithm and pulse contour analysis into a PC-based system with disposable sensors and to prospectively test the device for both safety and accuracy. Ultimately, Retia's device may help improve the outcomes of critically ill patients. PUBLIC HEALTH RELEVANCE: Blood flow can guide caregivers in treating sick patients, but there is currently no good way to measure it. Retia Medical will develop an effectively non-invasive blood flow monitor for sick patients that is easy-to-use and accurate and verify the device according to FDA requirements.