A HANDS-FREE LUNG AND CARDIOVASCULAR ASSESSMENT DEVICE (LCAD) FOR THE REMOTE CARE OF PATIENTS WITH CHRONIC CARDIOPULMONARY CONDITIONS

用于远程护理慢性心肺疾病患者的免提肺和心血管评估设备 (LCAD)

• 批准号: 10746641
• 负责人: Wilman Rene Ortega
• 金额: $ 0.65万
• 依托单位: MDDRIVEN LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10746641
• 关键词: Acceleration; Acute; Address; Adult; Affect; Agreement; Algorithms; American; Asthma; Auscultation; COVID-19 pandemic; Cardiac; Cardiopulmonary; Cardiovascular system; Caring; Cessation of life; Characteristics; Chest; Chronic; Chronic Obstructive Pulmonary Disease; Congestive Heart Failure; Country; Crackles; Data; Development; Device Designs; Devices; Diagnosis; Digital Signal Processing; Disease; Eko; Elderly; Electrocardiogram; Emergency department visit; Evaluation; Evidence based intervention; Evidence based treatment; Filtration; Flare; Freezing; Frequencies; Goals; Growth; Hand; Healthcare; Heart; Heart Rate; Home; Hospitalization; Implant; Knowledge; Lead; Left; Letters; Life; Location; Lung; Marketing; Medical; Medical Device; Minor; Morbidity - disease rate; Morphology; Noise; Orthopedics; Outcome; Patient Care; Patients; Performance; Persons; Phase; Population; Provider; Pulmonary Heart Disease; Questionnaires; Remote management; Respiratory Sounds; Safety; Shoulder; Small Business Innovation Research Grant; Stethoscopes; Surface; System; Technology; Telemedicine; Testing; Time; Transportation; United States; Wheezing; accurate diagnosis; asthmatic patient; blind; clinical diagnosis; cohort; commercial application; current pandemic; design; digital; disability; ergonomics; hazard; health disparity; improved; microphone; mortality; pandemic disease; physical property; physically handicapped; prevent; prototype; remote diagnosis; remote health care; remote monitoring; remote patient monitoring; safety testing; sound; technological innovation; transmission process; usability; virtual; volunteer

PROJECT SUMMARY The goal of this project is to develop a remote, hands free self-auscultation and electrocardiogram (EKG) device for at home use in the remote monitoring and management of patients suffering from chronic cardiopulmonary conditions. Chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF) and asthma are the most prevalent chronic cardiopulmonary diseases in this country affecting 4-10%, 1-3% and 8-19% of the population respectively and they frequently coexist in the same patient. CHF exacerbations is the leading cause of hospitalizations in people >65 years and COPD exacerbations alone represent the third leading cause of hospitalizations in the U.S. Acute exacerbations of such chronic conditions that lead to hospitalizations and death are unpredictable and require immediate diagnosis and treatment to prevent further decline. Currently in person evaluations with auscultation of lungs, heart and EKG are necessary to confidently diagnose such acute exacerbations, however they are not available to millions of people due to distance, transportation, and time constraints. The Covid-19 pandemic has made in-person evaluations unsafe for patients with chronic conditions. Current hand-held digital stethoscopes with EKG capability are not designed for telemedicine, too small for elderly and frail patients, are not hands-free for EKG, and do not allow posterior chest auscultation without a second operator resulting in a health disparity among people who are single or alone, frail, elderly or have physical disabilities. Development of a hands free, remote self-auscultation and EKG device for at home use will assist medical providers via telemedicine using real time cardiovascular data to make accurate diagnoses and deliver evidence based treatment, this can result in halting an exacerbation and prevent a hospitalization and death. Our team has developed a prototype called Lung and Cardiac Assessment Device (LCAD) that addresses all of these limitations with promising preliminary data. In this project, for specific aim 1 we will design and build LCAD’s 4 stethoscope heads, 3 permanent EKG leads, filtering algorithms, soft shell and perform safety testing. In specific aim 2 we will validate LCAD’s performance and ease of use in a cohort of 30 normal and diseased subjects as compared to a commercial digital stethoscope(eko) and gold standard EKG device. We expect 80% agreement on lung sound and characteristics, EKG quality and characteristics from LCAD’s stethoscope and EKG obtained from the posterior chest compared to Eko device and gold standard front chest EKG. A SUS score of 80.3 or higher from LCAD is also expected. In phase II, we will test LCAD’s ability to assist telemedicine clinicians in the remote diagnosis and management of COPD, CHF and Asthma patients. We expect LCAD to be an important part of the growing telemedicine- remote patient monitoring market valued at USD 45 billion in 2019, prior to the pandemic, and expected to witness a 15.1% CAGR from 2020 to 2027.

项目摘要 本项目的目标是开发一种远程、免提的自我听诊和心电图（EKG） 用于远程监测和管理患有慢性疾病的患者的家用设备 心肺状况慢性阻塞性肺疾病（COPD）、充血性心力衰竭（CHF） 和哮喘是最普遍的慢性心肺疾病在这个国家影响4- 10%，1-3%， 和8-19%的人群，并且它们经常在同一患者中共存。CHF恶化是 >65岁人群住院的主要原因，仅COPD急性加重就占第三位。 在美国住院的主要原因。这种慢性疾病的急性加重导致 住院和死亡是不可预测的，需要立即诊断和治疗，以防止进一步的 下降目前，有必要通过肺部、心脏和EKG听诊进行个人评估， 诊断这种急性加重，但由于距离，数百万人无法获得， 交通和时间限制。2019冠状病毒病大流行使得亲自评估对 慢性病患者。当前具有EKG功能的手持式数字听诊器的设计 对于远程医疗，对于老年人和体弱的患者来说太小，心电图不能免提，并且不允许后向 在没有第二名操作员的情况下进行胸部听诊，导致单身或 孤独、体弱、年老或身体残疾。开发一种免提、远程自我听诊和 家庭使用的EKG设备将通过使用真实的心血管数据的远程医疗来帮助医疗提供者 为了做出准确的诊断并提供基于证据的治疗，这可以导致停止恶化 避免住院和死亡我们的团队已经开发出一种叫做肺和心脏的原型 评估设备（LCAD），解决了所有这些限制与有前途的初步数据。在这 项目，具体目标1，我们将设计和建造LCAD的4个听诊器头，3个永久EKG导线， 过滤算法，软外壳和执行安全测试。在具体目标2中，我们将验证LCAD的性能 和易于使用的一个队列的30个正常和患病的受试者相比，商业数字 听诊器（eko）和金标准心电图设备。我们预计80%的肺音一致， LCAD听诊器的特征、EKG质量和特征以及从后部获得的EKG 与Eko设备和金标准前胸EKG进行比较。LCAD的SUS评分为80.3或更高， 也期待。在第二阶段，我们将测试LCAD在远程诊断中协助远程医疗临床医生的能力 以及COPD、CHF和哮喘患者的管理。我们希望LCAD成为 不断增长的远程医疗-远程患者监测市场在2019年价值450亿美元， 大流行，预计2020年至2027年复合年增长率为15.1%。