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A Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL116037-01
Agency Tracking Number: R43HL116037
Amount: $151,360.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA11-096
Timeline
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
20 SAXON WAY
NEW ROCHELLE, NY 10804-2006
United States
DUNS: 78284153
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MARC ZEMEL
 (914) 633-1433
 marc_zemel@yahoo.com
Business Contact
 MARC XEMEL
Phone: (914) 633-1433
Email: marc_zemel@yahoo.com
Research Institution
 Stub
Abstract

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.

* Information listed above is at the time of submission. *

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