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

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 rt65 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.