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Portable device for monitoring water balance in elderly

便携式老年人水平衡监测装置

基本信息

批准号：
8704442
负责人：
Armen Sarvazyan
金额：
$ 46.76万
依托单位：
ARTANN LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2017-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8704442
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

项目摘要

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(申请人提供)：脱水是老年人发病和死亡的常见原因。识别高危个体并保持足够的液体平衡是老龄化人口中卫生保健的一个重要组成部分。目前，还没有有效的工具来衡量水合状态并区分哪些人处于危险之中。目前的水分评估方法和标准，如口渴、皮肤肿胀、血压、脉搏、尿量和比重、MRI、稀释法和生物阻抗，其可靠性和有效性有限，方法不准确或昂贵。鉴于脱水既是可预防的，又是可逆的，因此需要一种易于执行的方法来检测水分失衡，这在临床上具有极其重要的意义。该项目的目标是开发一种廉价且易于使用的设备，并将其商业化，该设备可以监测水合状态的变化，并预测居家和住院老年人的风险。根据这笔赠款正在开发的水合监测仪(HM)可以客观地量化身体水分含量和水合状态的变化。在该装置中实施的专利方法是基于以下实验事实，即通过软组织的超声波速度是组织水分含量的线性函数。因为肌肉为身体提供了最大的水分蓄水池，所以通过测量肌肉中超声波的速度来评估水分失衡。在第一阶段的研究过程中，我们设计和组装了HM？原型，并在组织模型和切除的动物组织上对其进行了广泛的测试。基于这些测试的结果，我们设计了用于第二阶段临床研究的HM？原型。这个第二阶段SBIR项目的目标包括建造和测试八个HM？原型，并将原型提供给三个地点进行临床验证。人体研究的目标包括：在辅助生活设施中对老年人进行的纵向研究中，确定个体水化水平的正常日变化；评估处于正常生理水化状态的老年人个体水化基线之间的范围；建立HM评估因高钠脱水而住院的老年患者的初始和校正水化状态的能力；在常规测试的同时使用超声速度测量来确定水化和脱水阈值，以及检测健康的年轻成年人在经历3%急性脱水前后的水化状态的变化；并通过比较小腿和二头肌的数据来验证身体脱水是一个普遍的生理过程的假设，这些过程对所有身体肌肉都有同样的影响。第二阶段的活动将以开发试生产的HM原型和准备全面的工程文件为最终结果。该设备将致力于符合各自的FDA质量体系法规、良好制造规范和纳入Artann实验室质量体系的法规。