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: 10741296
• 负责人: Wilman Rene Ortega
• 金额: $ 5.5万
• 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/10741296
• 关键词: Acute; Address; Affect; Agreement; Algorithms; Asthma; Auscultation; COVID-19 pandemic; Cardiac; Cardiopulmonary; Cardiovascular system; Cessation of life; Characteristics; Chest; Chronic; Chronic Obstructive Pulmonary Disease; Congestive Heart Failure; Country; Data; Development; Devices; Diagnosis; Disease; Eko; Elderly; Electrocardiogram; Evaluation; Evidence based treatment; Goals; Hand; Heart; Home; Hospitalization; Life; Lung; Marketing; Medical; Minor; Patient Care; Patients; Performance; Persons; Phase; Population; Provider; Pulmonary Heart Disease; Remote management; Respiratory Sounds; Small Business Innovation Research Grant; Stethoscopes; Technology; Telemedicine; Testing; Time; Transportation; accurate diagnosis; asthmatic patient; cohort; design; digital; disability; health disparity; improved; pandemic disease; physically handicapped; prevent; prototype; remote diagnosis; remote health care; remote monitoring; remote patient monitoring; safety testing

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.

项目总结 该项目的目标是开发一种远程、免提的自听和心电图仪(EKG)。 一种用于慢性阻塞性肺疾病患者远程监护和管理的家用设备 心肺状况。慢性阻塞性肺疾病(COPD)、充血性心力衰竭(CHF) 哮喘是我国最常见的慢性心肺疾病，影响4%-10%，1%-3% 和8-19%的人群，它们经常共存于同一患者。充血性心力衰竭加重 65岁人群中住院的主要原因和COPD恶化本身就是第三大原因。 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 拒绝。目前，需要通过听诊对肺、心脏和EKG进行面对面评估，才能自信 诊断这种急性加重，但由于距离的原因，数百万人无法获得它们， 交通，以及时间限制。新冠肺炎大流行使得面对面的评估对 患有慢性病的患者。目前手持的具有EKG功能的数字听诊器不是设计的 对于远程医疗，对于年老体弱的患者来说，太小了，不能免提进行EKG，也不允许后置 在没有第二个操作员的情况下进行胸部听诊导致单身或 孤独、虚弱、年老或有肢体残疾。研制了一种免提、远程自听和 家庭使用的EKG设备将通过使用实时心血管数据的远程医疗帮助医疗提供者 为了做出准确的诊断并提供循证治疗，这可以阻止病情恶化。 并防止住院和死亡。我们的团队已经开发出一种名为肺和心脏的原型 评估设备(LCAD)，用有希望的初步数据解决了所有这些限制。在这 项目，针对特定目标1，我们将设计和制造LCAD的4个听诊头，3个永久性EKG导联， 过滤算法，软壳，并进行安全测试。在具体目标2中，我们将验证LCAD的性能 与商业数字相比，在30名正常和有疾病的受试者中使用的易用性 听诊器(EKO)和黄金标准EKG设备。我们希望80%的人同意肺音和 LCAD听诊器和后路EKG的特点、心电质量及特点 胸部对比EKO装置和黄金标准的前胸EKG。LCAD的SUS分数为80.3或更高 也在意料之中。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 以及慢性阻塞性肺病、充血性心力衰竭和哮喘患者的管理。我们期望LCAD成为 在2019年之前，不断增长的远程医疗-远程患者监护市场价值450亿美元 从2020年到2027年，预计年均增长率将达到15.1%。