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Mobile multifunctional tool for monitoring and management of respiratory diseases

用于监测和管理呼吸系统疾病的移动多功能工具

基本信息

批准号：
9262272
负责人：
Erica Silvia Forzani
金额：
$ 47.46万
依托单位：
TF HEALTH CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-04-16 至 2020-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9262272
关键词：
Acoustics Affect Algorithms Alpha Cell American Asthma Back Breath Tests Businesses Capnography Carbon Dioxide Cellular Phone Certification Chest Chronic Chronic Obstructive Airway Disease Clinic Clinical Clinics and Hospitals Communication Computer software Current Procedural Terminology Codes Data Display Data Storage and Retrieval Detection Development Devices Diagnosis Discrimination Disease Electromagnetics Equipment Gases Goals Guidelines Health Health Status Health Technology Hospitals Humidity Immune Industry Insurance Light Lighting Lung diseases Marketing Measurement Measures Medical Medical Device Medical center Monitor Patient Monitoring Patients Performance Phase Population Production Protocols documentation Quality Control Reaction Time Receiver Operating Characteristics Risk Assessment Safety Sales Sampling Sensitivity and Specificity Societies Spirometry Supervision Technology Temperature Test Result Testing Wireless Technology Work asthmatic patient consumer product cost design effective therapy handheld mobile device innovation instrument mHealth meetings nanocomposite pressure public health relevance pulmonary function quality assurance sensor signal processing success tool usability user-friendly verification and validation

项目摘要

DESCRIPTION (provided by applicant): Mobile multifunctional tool for monitoring and management of respiratory diseases Chronic Obstructive Pulmonary Disease (COPD) and asthma affect millions of people worldwide. Because there is no permanent cure for these diseases, efficient management of the patients is needed. New mobile health technologies, such as personal devices that allow patients to monitor their diseases under or near free- living conditions, will lower the cost, and thus contribute to the solution of the problem. Furthermore, continuous monitoring of the patients' health status afforded by the mobile devices will provide more complete information than the sporadic medical exams carried out currently in hospital or clinical settings. The most effective diagnosis and management technologies for COPD and asthma are spirometry and capnography. However, traditional low-cost spirometers are relatively inaccurate and lack of gas exchange information, and the capnography equipment is bulky, expensive, and difficult-to-operate without close supervision of professionals. These factors have limited spirometry and capnography to the use in hospital or clinic setting only. The present project aims at developing a personal device that can perform both capnography and spirometry for patients to use outside of hospitals and clinics. Creating such a device has been a challenge. To overcome the challenge, the Phase 1 part of the project has successfully developed and validated several innovations, including 1) a nanocomposite sensing material for accurate breath-by- breath analysis of carbon dioxide concentrations, 2) a low cost and high performance acoustic flow sensor that covers a wide dynamic range for both low flow-rate capnography and high flow-rate spirometry, 3) an adaptive sampling algorithm for correctly collecting the patient's breath without the presence of professionals, and 4) a cell phone application for signal processing. Building upon the success of Phase 1, this Phase 2 project will transform the technology into a real world solution for COPD and asthma patients by designing, building and testing a complete device with cell phone App, establishing manufacturing protocols, and preparing a FDA application. The project will bring together strengths of the sensor development and device fabrication at TF Health Co (doing business as Breezing Co.), sensor characterization and testing team at ASU, and clinical expertise of Banner Good Samaritan Medical Center to achieve the goal. The team has worked together and completed all the milestones in Phase 1, and is ready to overcome technical challenges and to develop the first wireless device with both spirometry and capnography capabilities.

描述（由申请人提供）：用于监测和管理呼吸系统疾病的移动的多功能工具慢性阻塞性肺病（COPD）和哮喘影响着全球数百万人。由于这些疾病没有永久的治愈方法，因此需要对患者进行有效的管理。新的移动的保健技术，如允许病人在自由生活条件下或接近自由生活条件下监测其疾病的个人设备，将降低成本，从而有助于解决问题。此外，由移动的设备提供的对患者健康状态的连续监测将提供比目前在医院或临床环境中进行的零星医学检查更完整的信息。 COPD和哮喘最有效的诊断和管理技术是肺功能测定和二氧化碳监测。然而，传统的低成本肺活量计相对不准确并且缺乏气体交换信息，并且二氧化碳监测设备体积庞大、价格昂贵并且在没有专业人员的密切监督的情况下难以操作。这些因素限制了肺量测定和二氧化碳监测仅在医院或诊所环境中使用。目前的项目旨在开发一种个人设备，可以执行二氧化碳和肺活量测定，供患者在医院和诊所之外使用。制造这样的设备是一个挑战。为了克服这一挑战，该项目的第一阶段部分已经成功开发并验证了几项创新，包括1）一种纳米复合传感材料，用于精确的二氧化碳浓度逐呼吸分析，2）一种低成本和高性能的声学流量传感器，可覆盖低流速二氧化碳监测和高流速肺量计的宽动态范围，3）自适应采样算法，用于在没有专业人员在场的情况下正确收集患者的呼吸，以及4）用于信号处理的手机应用程序。在第一阶段成功的基础上，第二阶段项目将通过设计、构建和测试带有手机应用程序的完整设备，建立制造协议，并准备FDA申请，将该技术转化为COPD和哮喘患者的真实的解决方案。该项目将汇集TF Health Co（以Breezing Co.的名义开展业务）的传感器开发和设备制造优势，ASU的传感器表征和测试团队以及Banner Good Samaritan医疗中心的临床专业知识来实现目标。该团队共同努力，完成了第一阶段的所有里程碑，并准备克服技术挑战，开发第一款具有肺功能和二氧化碳监测功能的无线设备。