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（由适用提供）：脱水通常是古老的发病率和死亡率的原因。确定处于风险的人并维持足够的流体平衡是 老龄化人口中医疗保健的重要组成部分。当前，尚无有效的工具来衡量水合状态并区分有风险的水平。可靠性和有效性o当前的水合评估方法和标准，例如第三，皮肤繁琐，血压，脉搏，尿液输出和比重，MRI，稀释方法和生物阻抗受到限制；这些方法不准确或昂贵。鉴于脱水既可以预防又可逆，因此需要一种易于表现的方法来检测水不平衡是至关重要的。该项目的目的是开发和商业化廉价且易于使用的设备，该设备可以监视水合状态的变化和预测在家庭界和机构化的风险上。在此赠款下开发的水合监视器（HM）可以客观地量化身体水含量和水合状态的变化。该设备中实施的专有专利方法是基于一个实验事实，即通过软组织进行超声速度是组织水含量的线性函数。由于肌肉为水提供了最大的身体晶状体，因此通过测量肌肉超声速度来进行水不平衡评估。在第一阶段研究的过程中，我们设计并组装了HM - prototype，在组织幻像和优秀的动物组织上进行了广泛的测试。基于这些测试的结果，我们为II期临床研究设计了HM—培训。该II阶段SBIR项目的目的包括建造和板凳测试八个HM` - 原型，并将原型提供给三个地点以进行临床验证。人类研究的目标包括：确定对辅助生活设施的纵向研究中单个水合水平的正常每日变化；评估在正常物理水合状态下基本水平基线之间的范围；建立HM评估入院高嗜热脱水的基本患者人群中最初和校正水合状态的能力；在与常规测试并行采用超声速度度量时，确定肠道和脱水阈值，并在接受3％急性脱水之前和之后检测年轻健康成年人水合状态的变化；并测试人体脱水是一种普遍的物理过程的假设，通过比较在小腿和二头肌肌肉上获得的数据，同样影响了所有身体肌肉。 II期活动将最终开发前制作的HM原型并准备全面的工程文档。该设备将旨在遵守相对的FDA质量系统法规，良好的制造实践和法规，这些法规纳入了Artann Laboratories质量系统。