A Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients

用于危重病人的微创心输出量监测装置

• 批准号: 8395053
• 负责人: Marc Zemel
• 金额: $ 15.14万
• 依托单位: RETIA MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8395053
• 关键词: Accounting; Achievement; Adopted; Algorithms; Blood Pressure; Blood flow; Cardiac Output; Caregivers; Caring; Catheters; Critical Illness; Databases; Detection; Devices; Diagnosis; Early Diagnosis; Family; Goals; Hemorrhage; Human; In Vitro; Legal patent; Marketing; Measures; Medical; Monitor; Morphologic artifacts; Movement; Nomograms; Outcome; Output; Patients; Phase; Physiologic pulse; Physiological; Physiology; Pulmonary artery structure; Radial; Safety; Sensitivity and Specificity; Shock; Simulate; Small Business Innovation Research Grant; Source; System; Testing; Time; Variant; Visual; base; disease diagnosis; experience; hemodynamics; improved; minimally invasive; monitoring device; non-compliance; prototype; research study; sensor

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.

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预后。然而，CO监测由于其侵入性而急剧下降。Retia Medical将提供一种设备，通过对许多患者已经测量过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”解释了生理学的关键方面，迄今为止，竞争性分析在血流动力学不稳定期间提供了卓越的准确性。这个SBIR项目的总体目标是建立一个原型设备来实现