SBIR Phase II: Electronic Measurement Device of Capillary Refill Time to Improve Outcomes from Sepsis

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase 2 project is a novel rapid automated external system for improving patient outcomes due to sepsis. Sepsis remains one of the most frequent causes of hospitalizations with 1.7M US cases annually, intensive care unit (ICU) admissions, reasons for patient deaths in the ICU, and one of the most common final pathways from infection to death. Each hour delay in the administration of antibiotics is associated with an 8% increase in mortality for septic shock patients and an 8% increase in the rate of progression to shock for severe sepsis patients. A delay in antibiotic administration of more than 1.5 hours in septic patients without shock is associated with 35% higher odds of mortality, and renders the patient at nearly 40% greater risk of stroke/heart attack (both ischemic and hemorrhagic) for up to 12 months post sepsis. The company’s novel approach automates and quantifies current manual, subjective methods for evaluating clinical circulatory measures used to diagnose sepsis, with the goal of integrating into clinical workflows for aiding treatment decisions including therapy IV fluids and vasopressors to maximize end-organ perfusion. The commercial impact of the first-generation project is to provide automated quantifiable measures of current digital manipulation in the 6M febrile patients reporting to emergency departments in the US each year, representing a total market of $3B. This Small Business Innovation Research (SBIR) Phase 2 project will enhance the usability and commercial readiness of the company’s device suitable for clinical utility. The system provides novel, rapid physiologic measures of capillary refill time indicative of sepsis in a noninvasive and quantifiable manner, via the use of a novel automated finger cradle. The project will build upon Phase 1 results of their patient device interface to include an advanced microprocessor capable of onboard signal processing and automation control. During the Phase 2 project the company will develop a novel mechanical architecture to enhance usability and durability of the system. Sensors and software will also be updated and the system automated. Additional research will also be performed and validated with waveform analysis algorithms to improve the repeatability and reliability of the signal. An onboard display and control algorithms will also be developed. Units will be constructed and tested to meet standards and clinical use requirements in accordance with regulatory requirements resulting in a manufacturable and reliable product design suitable for initial clinical use in the US. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.