Portable device for monitoring water balance in elderly

描述（由申请人提供）：脱水是老年人发病和死亡的常见原因。识别处于危险中的个体并保持足够的液体平衡是 老年人健康护理的重要组成部分。目前，还没有有效的工具来衡量水合状态和区分那些处于危险之中。目前的水化评估方法和标准，如口渴，皮肤肿胀，血压，脉搏，尿量和比重，MRI，稀释方法和生物阻抗的可靠性和有效性是有限的;这些方法是不准确的或昂贵的。鉴于脱水是可预防和可逆的，因此需要一种易于执行的检测水失衡的方法具有最大的临床重要性。该项目的目标是开发和商业化一种廉价和易于使用的设备，监测水化状态的变化，并预测在家和机构老年人的风险。根据这项资助正在开发的水合监测仪（HM）可以客观地量化身体含水量和水合状态的变化。在该设备中实施的专有专利方法是基于实验事实，即通过软组织的超声速度是组织含水量的线性函数。由于肌肉提供了最大的身体水库的水，水不平衡的评估是通过测量速度的超声波在肌肉。在第一阶段的研究过程中，我们设计并组装了HM-原型，并在组织模型和切除的动物组织上进行了广泛的测试。基于这些测试的结果，我们设计了HM-原型用于II期临床研究。该SBIR项目第二阶段的目标包括构建和台架测试8个HM原型，并将原型提供给三个地点进行临床验证。人体研究的目的包括：在对生活辅助设施中的老年人的纵向研究中确定个体水合水平的正常每日变化;评估处于正常生理水合状态的老年人的个体水合基线之间的范围;建立HM评估因高钠性脱水而入院的老年患者群体的初始和校正水合状态的能力;当采用超声速度测量与常规测试并行时，确定正常水合和脱水阈值，并检测年轻健康成年人在经历3%急性脱水之前和之后的水合状态的变化;并通过比较在小腿和二头肌上获得的数据来测试身体脱水是同等地影响所有身体肌肉的广义生理过程的假设。第二阶段的活动将最终开发一个预生产HM原型和准备全面的工程文件。该器械旨在符合各自的FDA质量体系法规、药品生产质量管理规范和纳入Artann Laboratories质量体系的法规。

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.