The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to improve the performance and quality of health care delivered by surgeons, perfusionists, intensive care physicians, respiratory therapists, and Extra Corporeal Membrane. Oxygenation (ECMO) specialists, while meeting substantial national/international marketplace needs for affordable, effective simulation training products for these medical professionals. By improving the quality of care delivered by these medical professionals, millions of patients will benefit annually due to reduced risk for death or disability along with better outcomes. Societal benefits include significant reductions in health care training costs and medical malpractice costs, which will reduce overall health care costs. Primary U.S. customer prospects for the data collection device and clinical scenario generation software include more than 150 teaching hospitals, 1,200 hospitals that have university affiliations, more than 2,800 hospitals that have cardiopulmonary ratings, and 2,000 unrated hospitals. Beyond these hospitals, a large base of global prospective customers is located in more than 5,400 thoracic surgery groups worldwide. Technological understanding will be enhanced from testing and expanding capabilities of biomedical training simulation systems. Scientific researchers will also benefit by having a powerful data collection device and clinical scenario generation software to conduct research. The proposed project not only addresses the present challenges regarding implementing affordable, effective simulation training. It provides an opportunity for students and practitioners to practice skills via simulations of patient cases rarely seen, including high-risk patient cases such as neonates and elderly with chronic conditions. Using the data collection device plus clinical scenario generation software coupled to a patient simulator they will be able to practice on a model patient before, during, and after the surgery or therapy to be performed. The project goal is to test the technical and commercial feasibility of the innovation via laboratory methods. Research objectives encompass: 1) Developing data capture/communication capabilities using commercial hospital data sets and laboratory generated data sets, 2) Developing database interface for parsing and extracting clinical data for creation of clinical scenarios, 3) Designing and laboratory testing of software engine and user interface module for generation of clinical scenarios. The anticipated technical results are: successful development of protocol sockets to access patient data from off-line databases, successful validation of patient data with simulator physiological models and algorithms, resolved issues of compatibility and/or differentials for heart-lung machine and ECMO derived data, and the ability to manually populate selected vacant variables/parameters.
