Clinical effectiveness of a wearable hydration device

可穿戴水化装置的临床效果

• 批准号: 10603046
• 负责人: Eamon Johnson
• 金额: $ 25.99万
• 依托单位: TRITONX INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603046
• 关键词: Accident and Emergency department; Achievement; Acute; Acute Renal Failure with Renal Papillary Necrosis; Adult; Affect; Aftercare; Ambulatory Care; Area; Body Composition; Body Fluids; Body measure procedure; Cardiovascular system; Caring; Cessation of life; Clinical; Clinical Trials; Clinical effectiveness; Communication; Complex; Congestive Heart Failure; Data; Data Science; Decision Making; Dehydration; Devices; Dialysis procedure; Disease; Effectiveness; Elderly; Emergency Care; Event; Expenditure; Extracellular Fluid; Fluid Shifts; Health; Health Status; Health behavior; Healthcare; Home; Hospital Costs; Hospitalization; Hospitals; Human body; Hydration status; Hypernatremia; Hypotension; Intake; Intracellular Fluid; Knowledge; Laboratories; Liquid substance; Measurement; Measures; Monitor; Morbidity - disease rate; Neurologic; Outcome; Outcome Study; Patient-Focused Outcomes; Patients; Phase; Population; Prevention strategy; Process; Randomized Controlled Trials; Recovery; Reporting; Research; Risk; Sample Size; Self Administration; Small Business Technology Transfer Research; Sodium; Spectrum Analysis; Survival Rate; Syncope; Techniques; Technology; Testing; Time; Vulnerable Populations; Water consumption; Work; Wrist; acute care; base; body system; care outcomes; care providers; cohort; comorbidity; cost; experience; falls; improved; light weight; monitoring device; mortality; novel strategies; prevent; sensor; telehealth; temporal measurement; time use; wearable sensor technology

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.

项目概要/摘要 老年人脱水每年花费数十亿美元的医疗费用。虽然并不总是主要焦点 护理方面，脱水是老年患者住院和死亡时普遍存在的合并症。脱水很重要 重要性，特别是对于弱势老年人来说，因为：(1) 老年人可能在监测方面遇到额外困难 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 家庭环境和老年人独立生活的其他区域的脱水。水合测量技术 今天提供给护理人员的信息要么不一致、费力、不准确，要么不可行。 脱水是一种对门诊护理敏感的疾病，是可以预防和逆转的。医疗保健结果可以是 通过家庭监测水合作用、健康状况的变化，改善并减少或预防医院支出 对老年人的行为进行及时、适当的护理。 TritonX 创造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 实时水合作用，具有足够的准确度来评估人体中显着的液体变化。我们的价值 提议是实时跟踪体液的变化，并在水合水平达到以下时提醒护理人员/患者 患者的病情跌至某个阈值以下。 在此 STTR 快速通道应用程序中，我们建议在第一阶段确定理想的用户体验、设备设置和 对老年人体内的液体水平进行连续监测时的卫生保健沟通需求 家园。在第二阶段，我们将进行一项随机对照试验，以检验持续居家的有效性 对在紧急护理环境中看到的一组易受伤害的老年患者的体液水平进行监测。 这项研究的成功结果将包括证明家用、可穿戴水袋的有效性的证据 监控设备、FDA 510(k) 和相关监管流程所需的数据以及对 我们对老年人需求和设备功能的了解。