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.

摘要 输血的临床门槛因疾病和医学专业的不同而不同，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的决定因素 输血，通常会导致一刀切的方法。尽管有时会挽救生命，但血液 输血也清楚地表明，输血会增加发病率和死亡率。因此，客观的衡量标准 为了实现以患者为中心的血液利用方法，需要对细胞氧合作用进行深入研究。一个 本申请中提出的对细胞氧合的非侵入性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，并帮助指导患者的临床决策。 通过测量和分析在可见光和近红外区的全光谱 源-探测器分离，Opticyte的CellSat-100将量化肌肉细胞中的肌红蛋白饱和度 与血管系统中的血红蛋白饱和度分开。自从红细胞(RBC)输注的目标 是通过增加血液携氧能力来改善细胞氧合能力，决定是否有 是否需要输血最好是基于输血前细胞氧合的知识。如果 没有细胞缺氧症，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 健康成人血氧饱和度(SCO2)。我们的第二阶段活动将集中在演示 用于准确、实时地测量健康和危重成人的血氧饱和度的概念。我们将建立一个 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 在西雅图一家大型地区性转诊医院的ICU进行一项试点研究。 这项建议的具体目标是：1)确保在我们的下一个- 第二代原型，CellSat-100；2)评估实时SCO2测量的准确性 CellSat-100在健康成年人的缺血期间，以及；3)检验以下假设：SCO2增加 在ICU患者中，RBC输注和最初的高血氧饱和度与更好的患者预后相关 人口。 CellSat-100将提供前所未有的关于细胞氧合的信息，这种信息具有主要的 对研究和临床护理的影响。该公司的长期目标是将一种 非侵入性监测仪，将提供强大和准确的二氧化碳分压测量。该装置具有广泛的应用前景 适用于重症监护，并将在救护车、急诊科、重症监护病房、 和手术室。CellSat-100将允许做出针对患者的临床决定，以防止 延长组织缺氧时间可改善临床结果。