Measuring Intra/Extracellular Volume and Hemodynamics

测量细胞内/外体积和血流动力学

• 批准号: 7268694
• 负责人: Leslie David Montgomery
• 金额: $ 58.79万
• 依托单位: LDM ASSOCIATES
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7268694
• 关键词: Age; Animal Model; Animals; Blood flow; Cell model; Cells; Chronic; Clinical; Clinical Trials; Clinical assessments; Computer Interface; Computer software; Computers; Condition; Copyright; Craniocerebral Trauma; Data; Development; Devices; Diagnosis; Dialysis patients; Dialysis procedure; Dysautonomias; Edema; Electrodes; End stage renal failure; Engineering; Equipment; Extracellular Fluid; Fatigue; Frequencies; Goals; Gold; Hydration status; Hypotension; Intercellular Fluid; Intracellular Fluid; Intracranial Hypertension; Investigation; Kidney Diseases; Legal patent; Liquid substance; Lymphedema; Marketing; Measurement; Measures; Medical; Modeling; Monitor; New York; Patients; Phase; Phase I Clinical Trials; Physical Dialysis; Physiological; Premature Infant; Preparation; Relative (related person); Renal dialysis; Reproducibility; Research; Research Design; Research Institute; Series; Space Flight; Staging; Standards of Weights and Measures; Syndrome; System; Tachycardia; Techniques; Testing; Time; Tissues; Trauma; United States Food and Drug Administration; Universities; Validation; Washington; base; college; commercialization; data acquisition; design; electric impedance; engineering design; extracellular; hemodynamics; human study; indexing; innovation; instrument; instrumentation; interstitial; nutrition; programs; prototype

DESCRIPTION (provided by applicant): LDM Associates (LDM) proposes to complete the development of their combined impedance plethysmographic (IPG) and electrical impedance spectroscopic (EIS) instrumentation that will allow noninvasive real-time relative measurement of segmental blood flow, intracellular, interstitial, and intravascular volumes. This instrument will be the first of its kind that can measure both blood flows and segmental compartment volumes. It will also be the only instrument that can be used to measure interstitial fluid volumes in addition to intra/extracellular volumes. In Phase I, LDM completed the design and fabrication of four prototype units and conducted a series of preliminary tests that demonstrated the feasibility of our proposed system and provided valuable information that was needed to refine the computer control data acquisition and analysis software that is an integral part of our instrumentation. In Phase II, LDM will further develop and optimize an IPG/EIS system to include a multi-segment interface, a bedside monitoring configuration, and advanced control/display software. In Phase II, a series animal and human studies will be performed to validate the instrumentation using "gold standard" compartment volume monitoring techniques. Additional human studies will be performed at New York Medical College and George Washington University to verify and demonstrate the use of the instrumentation to monitor segmental volume changes of end stage renal disease patients during dialysis. LDM will also finalize current preliminary arrangements for the intellectual protection, manufacture, marketing, and customer support of our instrumentation. This inexpensive, easy to use device will provide vital information in the treatment of diverse pathophysiologic fluid volume and hemodynamic states including, for example, the management of increased intracranial pressure following trauma, the treatment of disequilibrium and hypotension during renal dialysis, the monitoring of hydration state of premature infants, and the investigation and diagnosis of orthostatic intolerance associated with dysautonomia and space flight.

描述（由申请人提供）：LDM Associates（LDM）拟完成其组合阻抗体积描记（IPG）和电阻抗光谱（EIS）仪器的开发，该仪器将允许对节段性血流、细胞内、间质和血管内容积进行无创实时相对测量。该仪器将是第一个可以测量血流量和节段性室容积的仪器。它也将是除细胞内/细胞外容量外唯一可用于测量间质液容量的仪器。在第一阶段，LDM完成了四个原型装置的设计和制造，并进行了一系列初步测试，证明了我们提出的系统的可行性，并提供了有价值的信息，需要完善的计算机控制数据采集和分析软件，这是我们的仪器的一个组成部分。在第二阶段，LDM将进一步开发和优化IPG/EIS系统，以包括多段接口、床旁监护配置和高级控制/显示软件。在第二阶段，将进行一系列动物和人体研究，以验证仪器使用“金标准”室容量监测技术。将在纽约医学院和乔治华盛顿大学进行其他人体研究，以验证和证明使用仪器监测终末期肾病患者透析期间的节段性容积变化。LDM还将最终确定我们仪器的知识产权保护、制造、营销和客户支持的当前初步安排。这种廉价、易于使用的装置将在治疗不同的病理生理液体体积和血液动力学状态中提供重要信息，包括例如创伤后颅内压升高的管理、肾透析期间失衡和低血压的治疗、早产儿水合状态的监测以及与自主神经功能障碍和太空飞行相关的直立不耐受的研究和诊断。