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

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、急救医学和危重护理是恢复和维持细胞氧气水平 在病人身上。然而，目前还没有直接测量细胞氧气水平的临床设备。 虽然输注红细胞可以挽救生命，但它们有内在的风险和高昂的成本。输血决定 通常基于贫血的程度，通过测量红细胞压积进行评估，假设 输注红细胞(RBC)将增加对细胞的氧气输送。没有一丝蜂窝 氧合作用，目前尚不清楚输注红细胞是否能改善组织的氧气输送。 在每一个接受输血的人身上。 通过测量和分析在可见光和近红外区域的全光谱 源-探测器分离，Opticyte的细胞卫星™100将量化肌红蛋白饱和度或细胞饱和度 (SCO2)，在肌肉细胞中与血管系统中的血红蛋白饱和度分开。SCO2直接与 细胞内PO2通过肌红蛋白氧解离曲线。血氧饱和度监测有可能帮助 通过识别氧气供应不足的贫血患者来优化输血决策，这是有证据的 低血氧饱和度。 在我们的第二阶段SBIR项目中，我们已经为CellSat™设计和建造了一个概念验证原型 装置，并从手中获得了有希望的光谱。我们还成功地制造了SCO2 从我们的实验室原型手中获得的光谱的测量。我们已经完成了一个 关于一次性传感器的人的因素研究，并采访了医院环境中的关键意见领袖 定义设备的使用环境和工作流程。我们的第二阶段B活动将围绕 蜂窝卫星™100的开发，通过两个原型阶段到预制造。我们还将表演 肿瘤科门诊、住院及ICU的观察研究 血氧饱和度测定对优化输血决策的临床价值。 这项提议的具体目标是：1)开发和测试证明该设备的阿尔法原型 设计；2)开发和测试Beta原型，证明产品已经准备好；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 蜂窝卫星™100到制造业。 蜂窝卫星™100将提供前所未有的关于细胞氧合的信息，该信息具有主要的 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、重症监护和外科手术，并将在救护车、急诊科、 重症监护病房和手术室。

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.