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: 9328144
• 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 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9328144
• 关键词: Accident and Emergency department; Admission activity; Adult; Ambulances; Animal Experiments; Blood; Blood Transfusion; Blood capillaries; Cardiac; Caring; Carrying Capacities; Cell Hypoxia; Cells; Clinical; Color; Competence; Control Animal; Critical Care; Critical Illness; Data Set; Decision Making; Devices; Erythrocyte Transfusion; Erythrocytes; Evaluation; Explosion; Goals; Government; Hand; Hematocrit procedure; Hemoglobin; Hospital Referrals; Human; Hypoxia; Intensive Care Units; Ischemia; Knowledge; Left; Length; Light; 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; Trauma; 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.

摘要 输血的临床阈值因疾病和医学专业而异，并且主要基于 关于轶事的经验测量的红细胞压积是临床决策的最常见决定因素， 输血，往往导致一刀切的做法。虽然有时能救命， 输血也清楚地表明会增加发病率和死亡率。因此，客观的衡量 为了实现以患者为中心的血液利用方法，需要对细胞氧合进行研究。一 如本申请中所提出的，细胞氧合的非侵入性和连续测量将警告 临床医生对细胞缺氧的存在和程度，并帮助指导患者的具体临床决策。 通过测量和分析可见光和近红外区域的全光谱， Opticyte的CellSat-100将量化肌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， 如果需要输血，则最佳地基于输血前细胞氧合的知识。如果 没有细胞缺氧，输血可能是不必要的。 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内 血氧饱和度（ScO 2）在健康成人。我们的第二阶段活动将集中在证明- 用于准确、实时测量健康和重症成人ScO 2的概念。新的起点上建设更加富裕 紧凑的原型设备，可以很容易地在临床环境中使用。有了新的原型，我们将 在西雅图的一家主要地区转诊医院的ICU中进行试点研究。 本提案的具体目标是：1）在我们的下一个- 一代原型，CellSat-100; 2）评估实时ScO 2测量的准确性， CellSat-100在健康成人缺血期间的作用，以及; 3）测试ScO 2在缺血后增加的假设， RBC输注，并且初始高ScO 2与ICU患者的更好患者结局相关 人口 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。公司的长期目标是将 非侵入性监测仪，将提供可靠和准确的ScO 2测量。该设备具有广泛的 适用于重症监护，并可用于救护车、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， 延长组织缺氧，从而改善临床结果。