Metabolic and hemodynamic sensor for monitoring throughout the continuum of care

项目摘要 该项目将开发一种可穿戴的连续监测仪，用于报告和预测在 创伤、休克和败血症，目的是预测发病率、死亡率，并在医疗过程中提供反馈 干预。我也可以被用作分诊工具。拟议中的技术回应了已公布的技术差距 由国防部战斗伤亡护理研究计划和NIH特别关注的通知 创伤护理的生理监测和护理点技术。混合动力技术具有超强的 薄而灵活的多分析物传感器，放置在皮肤下，连接到可弯曲的可穿戴贴片上，用于非 有创血流动力学监测。这些技术共同提供了对血液的实时监测 氧合、心率、乳酸、组织氧、葡萄糖和pH。在目标1中，我们将设计和构建一个 微创连续葡萄糖、乳酸、氧气和pH传感器。已经证明，频繁的 对这些分析物的监测不仅可以确定初始损伤的风险，还可以预测发病率和结局 干预，并对与可能有重叠或隐蔽的创伤相关的医疗状况进行分层 症状。在目标2中，我们将设计和构建一个可穿戴的补丁，用于操作在目标1中开发的传感器 并进一步包括脉搏血氧饱和度、自主操作和无线的非侵入性技术 遥测技术。可穿戴设备和传感器都由提供舒适性和机械性的灵活电路组成 留置部件的匹配，以及可穿戴设备与皮肤的保形连接。在《目标3》中，我们将 使用猪出血性损伤模型和传感器引导复苏进行研究。在完成时 ，我们将拥有经过验证的监控技术，并可以开始申请 研究设备获得FDA豁免，可以进行人体研究。

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.