A Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients

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 accountsfor 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 analysisin 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 othersources. 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 artifactin 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 tomeasure 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.