权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

基本信息

批准号：
10396991
负责人：
LORILEE S. L. ARAKAKI
金额：
$ 91.08万
依托单位：
OPTICYTE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-04-01 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10396991
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

项目摘要

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。