I-Corps: Fluid Volume Responsiveness Monitor to Support the Care of Septic Patients

Regents Of The University Of Michigan - Ann Arbor, Ann Arbor MI

Investigators

Abstract

Sepsis is a whole-body inflammatory response to an infection, which affects more than 1 million Americans per year and results in about 258,000 deaths. It is one of the top four most costly conditions occurring in US hospitals, costing the healthcare system more than $20 B annually. Sepsis is treated using broad spectrum antibiotics. However, during treatment the heart's ability to pump blood throughout the body is reduced which can lead to organ failure. Therefore, intravenous fluids are used to maintain the volume of blood pumped per heart beat. While initially, providing fluids is essential, it can be harmful when the circulatory system cannot respond to additional fluid. Studies have shown that the early identification of when patients no longer need fluids can reduce the risk of death, speed recovery and decrease days spent on a ventilator. It is therefore critical to know when to stop giving the patient fluids and switch strategies to support blood flow. Current methods to perform these measurements, are inaccurate, invasive, and are not conducive to the care of septic patients. The proposed technology overcomes the limitations of current methods and can provide the continuous assessment of a patient?s fluid responsiveness. This system will empower emergency department and intensive care unit providers to collect fluid responsiveness data, which physicians can use to optimize patient care. The team envisions that optimizing sepsis care would decrease recovery times and reduce the number of deaths associated with sepsis. In addition, the proposed system will help hospitals achieve compliance with recently instituted sepsis quality regulations. The team plans to develop a physiologic measurement system for the accurate assessment of fluid volume responsiveness. The proposed technology could be incorporated into a product in numerous ways. For example, an automated, a low-profile ultrasound-based smart sensor patch could be developed. Alternately, the technology could be integrated with the software of existing ultrasound machines, or even a software package could be realized that integrates data from various hospital-based information sources. To determine the ideal solution the team intends to understand the user-buyer-payer interaction, as well as the regulatory and reimbursement landscape. The I-Corps program will help this team achieve this goal by enhancing its ability to develop a sound value proposition, business model, and commercialization strategy for our technology. Though an intensive customer discovery process the team will discover the best way to package our technology to meet the needs of customers.