Clinical effectiveness of a wearable hydration device

项目摘要/摘要 老年人的脱水每年要花费美国数十亿美元的医疗费用。虽然并不总是 护理，脱水是老年患者住院和死亡中普遍存在的共病。脱水是至关重要的 重要，特别是在脆弱的老年人中，因为：(1)老年人在监测方面可能有额外的困难 他们自己的液体摄入量(2)现有技术没有提供一致的、可操作的测量机制 在家庭环境和其他老年人独立生活的地区脱水。水化测量技术 今天提供给护理人员的服务要么不一致，要么费力，要么不准确，要么不可行。 脱水是一种对门诊护理敏感的疾病，是可以预防和可逆的。医疗保健结果可以是 通过家庭监测水合、健康变化，改善和减少或预防医院支出 对老年人的行为和呈现及时、适当的照顾。 TritonX开发了一种基于生物阻抗谱(BIS)技术的可穿戴传感器，用于测量个人 具有足够准确性的实时水合作用，可评估人体内显著的体液变化。我们的价值 建议是实时跟踪体液的变化，并警告看护/患者如果 病人会跌破某个临界点。 在此STTR Fast Track应用程序中，我们建议在第1阶段确定理想的用户体验、设备设置和 对老年人的体液水平进行持续监测时的医疗沟通需求 家。在第二阶段，我们将进行一项随机对照试验，以检验持续家庭的有效性 监测在紧急护理环境中看到的一组脆弱的老年患者的体液水平。 这项研究的成功结果将包括家庭可穿戴式补水的有效性的证据 监测设备、FDA 510(K)和相关监管流程所需的数据以及对以下方面的实质性改进 我们对老年人需求和设备功能的了解。

Project Summary/Abstract Dehydration among older adults costs billions of US healthcare dollars every year. While not always the primary focus of care, dehydration is a pervasive comorbidity in hospitalizations and deaths of older adult patients. Dehydration is of vital importance, especially among vulnerable older adults because: (1) Older persons can have additional difficulty monitoring their own fluid intake (2) existing technologies do not present a consistent, actionable mechanism for measuring dehydration in home settings and other areas where older adults live independently. Hydration measurement techniques available to care providers today are either inconsistent, laborious, inaccurate, or not feasible. Dehydration is an ambulatory-care-sensitive condition and is preventable and reversible. Health care outcomes can be improved and hospital expenditures reduced or prevented through home monitoring of hydation, changes in health behaviors of older adults and the rendering prompt, appropriate care. TritonX has created a wearable sensor based on bioimpedance spectroscopy (BIS) techniques to measure personal hydration in real time with sufficient accuracy to assess significant fluid changes in the human body. Our value proposition is to track the changes in the body fluids in real time and to alert the caretakers/patient if the hydration level of the patient falls below a certain threshold. In this STTR Fast Track Application we propose to, in Phase 1, determine the ideal user experience, device settings and health care communication needs when conducting continuous monitoring of fluid levels among older adults in their homes. In Phase 2, we will conduct a randomized controlled trial to examine the effectiveness of continuous home monitoring of fluid levels in a cohort of vulnerable older adult patients seen in the emergency care setting. The successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA 510(k) and related regulatory processes and substantial enhancements to both our knowledge of older adult needs and device functionality.