Portable device for monitoring water balance in elderly

便携式老年人水平衡监测装置

• 批准号: 8591530
• 负责人: Armen Sarvazyan
• 金额: $ 52.64万
• 依托单位: ARTANN LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8591530
• 关键词: Acute; Adult; Adverse effects; Affect; Aging; Animals; Assisted Living Facilities; Binding; Blood; Blood Pressure; Body Water; Body Weight Changes; Caregivers; Clinical; Clinical Research; Data; Dehydration; Dementia; Detection; Devices; Diagnostic; Dizziness; Documentation; Elasticity; Elderly; Engineering; Equilibrium; Female; Fluid Balance; Goals; Grant; Headache; Healthcare; Home environment; Hospitals; Hour; Human; Hydration status; Individual; Laboratories; Left; Legal patent; Life; Lightheadedness; Liquid substance; Longitudinal Studies; Magnetic Resonance Imaging; Marketing; Measurement; Measures; Methods; Monitor; Morbidity - disease rate; Muscle; Nausea; Nursing Homes; Osmolalities; Output; Patients; Persons; Pharmaceutical Preparations; Phase; Physical Examination; Physiologic pulse; Physiological Processes; Plasma; Population; Production; Regulation; Rehydrations; Reproducibility; Research Design; Risk; Sampling; Signs and Symptoms; Site; Skin; Small Business Innovation Research Grant; Specific Gravity; Speed; Staging; Sweat; System; Technology; Test Result; Testing; Thirst; Time; TimeLine; Tissues; Training; Ultrasonics; Ultrasonography; Urine; Validation; Validity and Reliability; Variant; Water; Water Intoxication; Water consumption; Xerostomia; aging population; animal tissue; base; biceps brachii muscle; clinical research site; design; feeding; high risk; human study; light weight; male; mental state; monitoring device; mortality; older patient; phase 1 study; phase 2 study; prevent; prototype; public health relevance; soft tissue; tissue phantom; tool; young adult

DESCRIPTION (provided by applicant): Dehydration is a frequent cause of morbidity and mortality in the elderly. Identifying at risk individuals and maintaining adequate fluid balance is an essential component of health care in aging population. Currently, there is no effective tool available to measure hydration status and distinguish those at risk. The reliability and validity o current hydration assessment methods and criteria such as thirst, skin turgor, blood pressure, pulse, urine output and specific gravity, MRI, dilution methods and bioimpedance, are limited; the methods are inaccurate or expensive. Given that dehydration is both preventable and reversible, the need for an easy-to-perform method for the detection of water imbalance is of the utmost clinical importance. The goal of this project is to develop and commercialize an inexpensive and easy-to-use device that monitors changes in hydration status and predicts at risk in home-bound and institutionalized elderly. The Hydration Monitor (HM) which is being developed under this grant can objectively quantify changes in the body water content and hydration status. The proprietary patented method implemented in the device is based on the experimental fact that ultrasound velocity through soft tissue is a linear function of the tissue water content. Because muscle provides the largest body reservoir for water, the assessment of water imbalance is conducted by measuring speed of ultrasound in muscle. In the course of Phase I studies we designed and assembled HM ¿-prototype, extensively tested it on tissue phantoms and excised animal tissues. Based on the results of these tests we designed the HM ¿-prototype for Phase II clinical studies. The aims of this Phase II SBIR project include building and bench-testing eight HM ¿-prototypes and providing the prototypes to three sites for clinical validation. The objectives of human studies include: to determine normal daily variation of the individual hydration level in longitudinal study on elderly in assisted living facility; to assess range between individual hydration baselines for elderly in a normal physiologically hydrated state; to establish the ability of the HM to assess initial and corrected hydration status in a population of elderly patients admitted to the hospital for hypernatremic dehydration; to determine euhydration and dehydration thresholds when employing ultrasound velocity measures in parallel with conventional tests and to detect changes in the hydration status of young healthy adults before and after undergoing 3% acute dehydration; and to test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles. The Phase II activities will culminate with developing a pre-production HM prototype and preparing comprehensive engineering documentation. The device will aim to comply with respective FDA Quality System Regulations, Good Manufacturing Practices and regulations which are incorporated into Artann Laboratories quality systems.

描述（由申请人提供）：脱水是老年人发病和死亡的常见原因，识别高危人群并保持足够的液体平衡至关重要。 目前，还没有有效的工具来测量水合状态并区分当前水合评估方法和标准（例如口渴、皮肤肿胀、血压、脉搏）的可靠性和有效性。 、尿量和比重、MRI、稀释方法和生物阻抗都有限；鉴于脱水是可以预防和可逆的，因此需要一种易于执行的方法来检测水失衡。昂贵的该项目的目标是开发和商业化一种廉价且易于使用的设备，用于监测水合状态的变化并预测居家和收容老年人的风险。该设备中实施的专有专利方法可以客观地量化身体水分含量和水合状态的变化，该方法基于超声波穿过软组织的速度是组织肌肉水分含量的线性函数的实验事实。提供最大的身体水库对于水，水失衡的评估是通过测量肌肉中的超声波速度来进行的。在第一阶段研究过程中，我们设计并组装了 HM ¿ -原型，主要在组织模型和切除的动物组织上进行测试，根据这些测试的结果，我们设计了 HM ¿ -II 期临床研究的原型。该 II 期 SBIR 项目的目标包括构建和测试 8 个 HM ¿ - 原型并向三个地点提供原型进行临床验证，其目的包括：确定辅助生活设施中老年人的纵向研究中个体水合水平的正常每日变化；评估老年人的个体水合基线之间的范围。正常的生理水合状态；建立 HM 评估因高钠脱水入院的老年患者群体的初始和校正水合状态以确定水合和脱水的能力；与传统测试并行使用超声波速度测量时的阈值，并检测年轻健康成年人在经历 3% 急性脱水之前和之后水合状态的变化，并检验身体脱水是一种普遍的生理过程，对所有身体肌肉都有同样影响的假设；通过比较小腿和二头肌获得的数据，第二阶段活动将开发预生产 HM 原型并准备全面的工程文件，旨在遵守 FDA 各自的质量体系法规、良好制造规范和法规。已纳入 Artann Laboratories 质量体系。