Noninvasive compact device to monitor myoglobin saturation in anemia and critical illness

无创紧凑型设备，用于监测贫血和危重疾病中的肌红蛋白饱和度

• 批准号: 9974985
• 负责人: LORILEE S. L. ARAKAKI
• 金额: $ 99.86万
• 依托单位: OPTICYTE, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9974985
• 关键词: Accident and Emergency department; Advanced Development; Algorithms; Ambulances; Anemia; Blood; Blood Transfusion; Caring; Cell Hypoxia; Cells; Cessation of life; Clinical; Color; Critical Care; Critical Illness; Data Collection; Development; Device Designs; Devices; Dissociation; Emergency Medicine; Environment; Erythrocyte Transfusion; Erythrocytes; Explosion; Goals; Hand; Hematocrit procedure; Hemoglobin; Hospitals; Human; Individual; Inpatients; Intensive Care Units; Interview; Investigation; Laboratories; Lead; Life; Light; Measurement; Measures; Medical; Modeling; Monitor; Muscle Cells; Myoglobin; Near-Infrared Spectroscopy; Observational Study; Oncology; Operating Rooms; Operative Surgical Procedures; Optics; Organ; Organ failure; Outpatients; Oxygen; Oxygen saturation measurement; Patient-Focused Outcomes; Patients; Performance; Phase; Physiologic pulse; Process; Prospective Studies; Pulse Oximetry; Research; Risk; Savings; Shock; Skeletal Muscle; Skin; Small Business Innovation Research Grant; Source; Spectrum Analysis; Testing; Therapeutic; Time; Tissues; Training; Transfusion; Validation; base; cell injury; clinical care; clinically significant; cost; design; detector; improved; instrument; interpatient variability; meetings; monitoring device; non-invasive monitor; oncology service; optical spectra; prototype; safety testing; sensor; standard of care; transfusion medicine; usability; verification and validation; ward

ABSTRACT Adequate oxygen inside cells is critical for healthy organ function, and the main goal of clinicians in transfusion medicine, emergency medicine, and critical care is to restore and maintain cellular oxygen levels in patients. However, at this time, there is no clinical device that directly measures cellular oxygen levels. While RBC transfusions can be life-saving, they have inherent risks and high costs. Transfusion decisions are usually based on the degree of anemia, assessed by a hematocrit measurement, with the assumption that a red blood cell (RBC) transfusion will increase oxygen delivery to cells. Without a measure of cellular oxygenation, it is currently unknown if RBC transfusions improve the delivery of oxygen to tissues in general and in each individual who receives a transfusion. By measuring and analyzing full optical spectra in the visible and near-infrared regions at multiple source-detector separations, Opticyte’s CellSat™ 100 will quantify myoglobin saturation, or cellular saturation (ScO2), in muscle cells separately from hemoglobin saturation in the vasculature. ScO2 is directly related to intracellular pO2 via the myoglobin oxygen dissociation curve. ScO2 monitoring has the potential to help optimize transfusion decisions by identifying anemic patients with inadequate oxygen delivery, as evidenced by low ScO2. In our Phase II SBIR project, we have designed and built a proof-of-concept prototype for the CellSat™ device and have obtained promising spectra from the hand. We have also successfully made ScO2 measurements from spectra acquired from the hand with our laboratory prototype. We have completed a human factors study on the disposable sensor and have interviewed key opinion leaders in the hospital setting to define the use environment and workflow for the device. Our Phase IIB activities will revolve around development of the CellSat™ 100, through two prototype stages to pre-manufacturing. We will also perform an observation study in the outpatient and inpatient oncology services and in the ICU to demonstrate the clinical value of ScO2 measurement to optimize transfusion decisions. The Specific Aims of this proposal are to: 1) develop and test the Alpha Prototype that proves the device design; 2) develop and test the Beta Prototype that proves the product is ready; 3) integrate algorithm into Beta Prototype; 4) define the relationship between anemia and cellular oxygenation, and 5) transfer the CellSat™ 100 to manufacturing. The CellSat™ 100 will provide unprecedented information about cellular oxygenation that has major implications for both research and clinical care. The device has broad applicability to transfusion medicine, emergency medicine, critical care, and surgery, and will be useful in ambulances, emergency departments, intensive care units, and operating rooms.

摘要 细胞内充足的氧气对健康的器官功能至关重要，临床医生的主要目标是 输血医学、急诊医学和重症监护的主要任务是恢复和维持细胞氧水平 在病人身上。然而，目前还没有直接测量细胞氧水平的临床设备。 虽然红细胞输血可以挽救生命，但它们具有固有的风险和高成本。输血决策 通常基于贫血的程度，通过红细胞压积测量进行评估，并假设 红细胞（RBC）输血将增加细胞的氧气输送。如果没有细胞的测量 氧合，目前尚不清楚红细胞输注是否能改善氧向组织的输送 以及每一个接受输血的人。 通过测量和分析可见光和近红外区域的全光谱， 通过源-检测器分离，Opticyte的CellSat™ 100将量化肌红蛋白饱和度或细胞饱和度 （ScO 2），在肌肉细胞中与血管系统中的血红蛋白饱和度分开。ScO 2直接与 通过肌红蛋白氧解离曲线测定细胞内pO 2。ScO 2监测可能有助于 通过识别氧气输送不足的贫血患者来优化输血决策， 低sco 2 在我们的第二阶段SBIR项目中，我们设计并建造了CellSat™的概念验证原型 设备，并已获得有前途的光谱从手中。我们还成功地制造了ScO 2 从我们的实验室原型的手获得的光谱测量。我们已经完成了一 一次性传感器的人为因素研究，并采访了医院环境中的关键意见领袖 定义器械的使用环境和工作流程。我们的IIB期活动将围绕 CellSat™ 100的开发，通过两个原型阶段到预制造。我们还将表演 一项在门诊和住院肿瘤服务以及ICU中进行的观察研究， ScO 2测量对优化输血决策的临床价值。 该提案的具体目标是：1）开发和测试证明该设备的Alpha原型 设计; 2）开发和测试Beta原型，证明产品已经准备就绪; 3）将算法集成到 Beta原型; 4）定义贫血和细胞氧合之间的关系，以及5）将 CellSat™ 100用于生产。 CellSat™ 100将提供有关细胞氧合的前所未有的信息， 对研究和临床护理的影响。该装置对输液医学具有广泛的适用性， 急诊医学、重症监护和外科，并且将在救护车、急诊科、 重症监护室和手术室