Metabolic and hemodynamic sensor for monitoring throughout the continuum of care

用于在整个护理过程中进行监测的代谢和血流动力学传感器

• 批准号: 10659906
• 负责人: Elliot Lawrence Botvinick
• 金额: $ 61.32万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659906
• 关键词: Address; Admission activity; Alkalosis; American; Area; Blood; Continuity of Patient Care; Control Groups; Data; Department of Defense; Devices; Diabetes Mellitus; Diagnosis; Early Diagnosis; Educational workshop; Environment; Feedback; Glucose; Goals; Grant; Health Sciences; Health Services Research; Heart Rate; Hemoglobin; Hemorrhage; Hospitals; Human; Hybrids; In Vitro; Injury; International; Intervention; Intramuscular; Lactic Acidosis; Legal patent; Measurement; Measures; Mechanics; Medical; Metabolic; Monitor; Morbidity - disease rate; National Institute of Biomedical Imaging and Bioengineering; Obstructive Lung Diseases; Operative Surgical Procedures; Outcome; Oxygen; Patients; Performance; Peripheral; Physiologic Monitoring; Physiological; Point of Care Technology; Process; Publishing; Pulse Oximetry; Recommendation; Reporting; Research; Respiratory Acidosis; Resuscitation; Risk; Running; Sepsis; Shock; Signal Transduction; Skin; Symptoms; System; Technology; Telemetry; Testing; Time; Tissues; Training; Transportation; Trauma; Triage; United States National Institutes of Health; University Health Services; Work; casualty care; clinical research site; combat casualty; data exchange; design and construction; flexibility; glucose sensor; glycemic control; heart rate monitor; heart rhythm; hemodynamics; human subject; improved; improved outcome; in vivo; injured; interest; minimally invasive; mortality; operation; point of injury; porcine model; programs; prolonged field care; real time monitoring; research and development; sensor; sensor technology; standard of care; subcutaneous; tool; transmission process; trauma care; trend; vasoconstriction; wireless; wireless transmission

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.

项目摘要 本项目将开发一种可穿戴的连续监测器，用于报告和预测生理状态， 创伤、休克和败血症，目的是预测发病率、死亡率，并在医疗期间提供反馈。 干预我也可以作为一个分类工具。拟议的技术回应了公布的技术差距 由国防部战斗伤亡护理研究计划和国家卫生研究院特别关注的通知 创伤护理的生理监测和护理点技术。混合动力技术具有超- 薄的柔性多分析物传感器放置在皮肤下，附着在柔性可穿戴贴片上，用于非 有创血流动力学监测。这些技术一起提供了血液的真实的时间监测 氧合，心率，乳酸，组织氧，葡萄糖和pH值。在目标1中，我们将设计和构建一个 用于葡萄糖、乳酸盐、氧气和pH的微创连续传感器。 监测这些分析物不仅可以识别初始损伤的风险，而且可以预测发病率和结果， 干预，以及与创伤相关的分层医疗状况，这些创伤可能具有重叠或隐蔽的 症状在目标2中，我们将设计和构建一个可穿戴贴片，用于操作目标1中开发的传感器 并且还包括脉搏血氧测定、自主操作和无线通信的非侵入性技术。 遥测技术可穿戴设备和传感器都由柔性电路制成，提供舒适性和机械性能。 留置部件的匹配以及可穿戴物与皮肤的适形附接。在目标3中， 使用出血性损伤和传感器引导复苏的猪模型进行研究。完成时 我们将拥有经过验证的监测技术，并可以开始申请 FDA的试验用器械豁免，以继续进行人体研究。