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: 10480550
• 负责人: Wilman Rene Ortega
• 金额: $ 29.97万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10480550
• 关键词: 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; Frail Elderly; Freezing; Frequencies; Goals; Gold; Growth; Hand; Head; Healthcare; Heart; Heart Rate; Home; Hospitalization; Implant; Knowledge; Lead; Left; Letters; Life; Location; Lung; Medical; Medical Device; Minor; Morbidity - disease rate; Morphology; Noise; Orthopedics; Outcome; Patient Care; Patients; Performance; Persons; Phase; Population; Provider; Pulmonary Heart Disease; Questionnaires; Respiratory Sounds; Safety; Savings; Shoulder; Small Business Innovation Research Grant; Stethoscopes; Surface; System; Technology; Telemedicine; Testing; Time; Transportation; United States; Wheezing; accurate diagnosis; asthmatic patient; base; blind; clinical diagnosis; cohort; commercial application; design; digital; disability; 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; 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 该项目的目的是开发遥远的，无权的自我培养和心电图（EKG） 用于远程监控和管理患者的远程监控和管理的设备 心肺疾病。慢性阻塞性肺疾病（COPD），充血性心力衰竭（CHF） 哮喘和哮喘是该国最普遍的慢性心肺疾病，影响4-10％，1-3％ 和8-19％的人口，他们经常在同一患者中共存。 CHF加剧是 人口> 65岁的住院的主要原因，仅COPD加剧就代表了第三个 美国住院的主要原因是这种慢性疾病的急性加剧，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 衰退。目前以肺部，心脏和心电为生的人亲自进行评估。 诊断出这种急性加重，但是由于距离，数以百万计的人无法使用 运输和时间限制。 COVID-19大流行使现场评估不安全 患有慢性疾病的患者。当前具有EKG功能的手持手持数字听诊器不是设计的 对于远程医疗而言，对于老年和脆弱的患者而言太小，对于EKG而言，不允许手提 胸部听诊没有第二操作员，导致单身或单身人士的健康差异 独自一人，脆弱，长期存在或患有身体残疾。开发免费的远程自我灌输和 用于家庭使用的心电图设备将使用实时心血管数据通过远程医疗来帮助医疗提供者 为了进行准确的诊断并提供基于证据的治疗，这可能导致停止恶化 并防止住院和死亡。我们的团队开发了一个名为肺和心脏的原型 评估设备（LCAD）通过承诺初步数据来解决所有这些限制。在这个 项目，对于特定目的1，我们将设计和建造LCAD的4个听诊器头，3个永久性心电铅， 过滤算法，软外壳和执行安全测试。在特定目标2中，我们将验证LCAD的性能 与商业数字相比 听诊器（EKO）和金标准心电图设备。我们预计肺部声音达成80％的协议 LCAD听诊器和从后部获得的LCAD的特征，心电图和特征 胸部与EKO设备和金标准前胸部心电图相比。 LCAD的SUS得分为80.3或更高 也期望。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 在2019年，远程医疗 - 远程患者监测市场的价值为450亿美元 大流行，预计将在2020年至2027年期间见证15.1％的复合年增长率。