Early detection of ongoing hemorrhage (OH) before onset of shock is a universally acknowledged great unmet need, and particularly important after trauma. Delays in the detection of OH are associated with a ?failure to rescue? and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. While uniplex noninvasive technologies have failed to detect or diagnose complex disease states, we have demonstrated the superiority of multiplex approaches in silico. The goal of this STTR project is to develop a commercially viable optoimpedance sensor-based system that combines state-of-the-art noninvasive sensing technologies and advanced multivariable statistical algorithms. Phase I will involve three Aims: 1) D?esign, Fabricate and Test Opto-Impedance oPiic sensors, 2) Develop of Mobile App, Data and ML Pipeline on Secure Cloud, and 3) Evaluate oPiics on an Unanesthetized Upright Porcine Hemorrhage Model. By derisking the hardware challenges, we will be well-positioned for a Phase II application to optimize oPiic design and manufacturing, fold-in predictive algorithms under current development with DOD support, and validate with a clinical trial in critical care setting.
We have demonstrated that a multiplex approach is superior to predicting shock compared to single clinical devices alone. During a mass-casualty event, a predictive tool would need to be deployed widely, since only a fraction of individuals will have ongoing hemorrhage that will progress to decompensated shock. Optical and bioimpedance signals are critical indicators of muscle hemodynamics and electrolyte balance likely to be modified in the period leading up to shock. No commercial device exists that provides continuous, low-power, low-cost monitoring of these signals with characteristics suitable for integration with the multiplexing approach. This STTR application seeks Phase I funding to commercialize an opto-impedance sensor, called the ?oPiic?, that will address this unmet need.
