Real-time myoglobin saturation measurement to assess benefit of RBC transfusion

实时肌红蛋白饱和度测量以评估红细胞输血的益处

• 批准号: 9181365
• 负责人: LORILEE S. L. ARAKAKI
• 金额: $ 50万
• 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 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9181365
• 关键词: Accident and Emergency department; Admission activity; Adult; Ambulances; Animal Experiments; Blood; Blood Transfusion; Blood capillaries; Burn Trauma; Cardiac; Caring; Carrying Capacities; Cell Hypoxia; Cells; Clinical; Color; Control Animal; Critical Care; Critical Illness; Data Set; Decision Making; Devices; Erythrocyte Transfusion; Evaluation; Explosion; Goals; Government; Hand; Hematocrit procedure; Hemoglobin; Hospital Referrals; Human; Hypoxia; Intensive Care Units; Ischemia; Knowledge; Left; Length; Light; Marketing; Measurement; Measures; Medical; Modeling; Monitor; Morbidity - disease rate; Muscle Cells; Myoglobin; Near-Infrared Spectroscopy; Operating Rooms; Optics; Outcome; Oxygen; Oxygen saturation measurement; Patient-Focused Outcomes; Patients; Performance; Persons; Phase; Physiologic pulse; Pilot Projects; Process; Pulse Oximetry; Recovery; Research; Rest; Skeletal Muscle; Skin; Small Business Technology Transfer Research; Source; Spectrum Analysis; Stroke; Technology; Testing; Therapeutic; Time; Tissues; Training; Transfusion; Universities; Venous; Washington; Work; base; capillary; clinical care; detector; experience; improved; medical specialties; monitoring device; mortality; next generation; optical spectra; patient oriented; patient population; prevent; prototype; temporal measurement; tissue phantom

ABSTRACT Clinical thresholds for blood transfusions vary by illness and medical specialty, and are largely based on anecdotal experience. Measured hematocrit is the most frequent determinant for clinical decisions to transfuse blood, often resulting in a one-size-fits-all approach. Although lifesaving at times, blood transfusions have also been clearly shown to increase morbidity and mortality. Thus, an objective measure of cellular oxygenation is needed to work toward a patient-centered approach to blood utilization. A noninvasive and continuous measurement of cellular oxygenation, as proposed in this application, will alert clinicians to the presence and degree of cellular hypoxia and help direct patient-specific clinical decisions. By measuring and analyzing full optical spectra in the visible and near-infrared regions at three source-detector separations, Opticyte's CellSat-100 will quantify myoglobin saturation in muscle cells separately from hemoglobin saturation in the vasculature. Since the goal of red blood cell (RBC) transfusion is to improve cellular oxygenation by increasing blood oxygen carrying capacity, decisions about whether a transfusion is needed would optimally be based on knowledge of pre-transfusion cellular oxygenation. If there is no cellular oxygen deficiency, a transfusion may be unnecessary. In our ongoing Phase I STTR project, we have demonstrated the feasibility of measuring cellular oxygen saturation (ScO2) in healthy adults. Our Phase II activities will center on demonstrating proof-of- concept for accurate, real-time measurement of ScO2 in healthy and critically ill adults. We will build a compact prototype device that can be easily used in a clinical setting. With the new prototype, we will perform a pilot study in an ICU of a major regional referral hospital in Seattle. The Specific Aims of this proposal are to: 1) confirm sufficient spectral quality and stability in our next- generation prototype, the CellSat-100; 2) evaluate the accuracy of real-time ScO2 measurements with the CellSat-100 in healthy adults during ischemia, and; 3) test the hypotheses that ScO2 increases following RBC transfusion, and that initial high ScO2 correlates with better patient outcomes in an ICU patient population. The CellSat-100 will provide unprecedented information about cellular oxygenation that has major implications for both research and clinical care. The long-term goal of the company is to market a noninvasive monitor that will provide robust and accurate measurements of ScO2. The device has broad applicability to critical care, and will be useful in ambulances, emergency departments, intensive care units, and operating rooms. The CellSat-100 will allow patient-specific clinical decisions to be made that prevent prolonged tissue hypoxia leading to improve clinical outcomes.

抽象的 输血的临床阈值因疾病和医学专业而异，并且很大程度上基于 关于轶事经历。测量的血细胞比容是临床决策的最常见决定因素 输血，通常会采取一刀切的方法。尽管有时可以挽救生命，但血液 输血也已被明确证明会增加发病率和死亡率。因此，客观衡量 需要细胞氧合作用以实现以患者为中心的血液利用方法。一个 如本申请中所提出的，对细胞氧合的无创和连续测量将发出警报 临床医生了解细胞缺氧的存在和程度，并帮助指导针对患者的具体临床决策。 通过测量和分析三个可见光和近红外区域的完整光谱 源-检测器分离，Opticyte 的 CellSat-100 将量化肌肉细胞中的肌红蛋白饱和度 与脉管系统中的血红蛋白饱和度分开。由于红细胞（RBC）输注的目标 是通过增加血液携氧能力来改善细胞氧合，决定是否 是否需要输血最好基于输血前细胞氧合的知识。如果 没有细胞缺氧，可能不需要输血。 在我们正在进行的第一阶段 STTR 项目中，我们已经证明了测量细胞的可行性 健康成人的血氧饱和度 (ScO2)。我们的第二阶段活动将集中于展示证明- 准确、实时测量健康和危重成人的 ScO2 的概念。我们将建立一个 紧凑的原型设备，可以在临床环境中轻松使用。通过新的原型，我们将 在西雅图一家主要地区转诊医院的 ICU 进行试点研究。 该提案的具体目标是：1）在我们的下一步中确认足够的光谱质量和稳定性 一代原型机，CellSat-100； 2) 评估实时 ScO2 测量的准确性 CellSat-100 在健康成人缺血期间的作用； 3) 检验 ScO2 在以下情况下增加的假设 红细胞输血以及初始高 ScO2 与 ICU 患者更好的患者预后相关 人口。 CellSat-100 将提供前所未有的有关细胞氧合的信息，该信息具有重大意义 对研究和临床护理的影响。公司的长期目标是营销 无创监测仪将提供可靠且准确的 ScO2 测量。该设备具有广泛的 适用于重症监护，并将适用于救护车、急诊室、重症监护室、 和手术室。 CellSat-100 将允许做出针对患者的临床决策，以防止 长期组织缺氧可改善临床结果。