Metabolic and hemodynamic sensor for monitoring throughout the continuum of care

Project Summary
This project will develop a wearable continuous monitor for reporting and predicting physiological state during
trauma, shock and sepsis with the goal of predicting morbidity, mortality, and providing feedback during medical
intervention. I can also be used as a triage tool. The proposed technology responds to technology gaps published
by the Department of Defense Combat Casualty Care Research Program and an NIH Notice of Special Interest
in Physiological Monitoring and Point of Care Technologies for Trauma Care. The hybrid technology has an ultra-
thin flexible multiple analyte sensor placed just under the skin attached to a flexible wearable patch for non-
invasive hemodynamic monitoring. Together these technologies provide real time monitoring of blood
oxygenation, heart rate, lactate, tissue oxygen, glucose, and pH. In Aim 1 we will design and construct a
minimally invasive continuous sensor for glucose, lactate, oxygen and pH. It has been shown that frequent
monitoring of these analytes not only identifies risk at initial injury, but can predict morbidity and outcomes, guide
intervention, and stratify medical conditions associated with trauma that may have overlapping or cryptic
symptoms. In Aim 2 we will design and construct a wearable patch that operates the sensor developed in Aim1
and further includes the non-invasive technology of pulse oximetry, autonomous operation, and wireless
telemetry. The wearable and sensor are both made of flexible circuits providing comfort and mechanical
matching of the indwelling component, and conformal attachment of the wearable to the skin. In Aim 3 we will
conduct a study using a porcine model of hemorrhagic injury and sensor-guided resuscitation. At the completion
of the grant, we will have a validated monitoring technology and can begin the process of applying for an
Investigational Device Exemption from the FDA to proceed to human studies.

Grant Number: 5R01EB033417-04
NIH Institute/Center: NIH
Principal Investigator: Elliot Botvinick