Medical home monitoring of vital signs for COVID-19

cosinuss° proposes a medical home monitoring solution, primarily reaching out to low and medium risk patients of COVID-19 who are in home isolation. The monitoring system consists of an in-ear wearable sensor (cosinuss° Two), a mobile device application (cosinuss° LabApp) and a server database (cosinuss° LabServer). Advanced algorithms digitally evaluate the health status based on the continuous measurement of key physiological vital parameters – independent of the person’s location:

  • Core body temperature
  • Heart rate
  • Blood oxygen saturation 
  • Respiration rate

The mobile monitoring of vital parameters in combination with the advantages of telemedicine creates a new healthcare infrastructure making the pandemic outbreak of COVID-19 and other future diseases more manageable:

  • Continuous remote patient monitoring in home isolation
  • Minimization of infection risk of hospital staff and inpatients
  • Optimally running hospitals and testing labs, in accordance with their capacities
  • Accurate data basis for early medical studies

The healthcare system is under pressure due to the rising burden of COVID-19

Sars-CoV-2 spread already over more than 150 countries within weeks and more than 198.000 cases of Covid-19 (Fig.1) are confirmed worldwide.1 The disease spreads rapidly and the number of infected patients closely follows an exponential trend.2

A vaccine or a successful treatment are not available right now. As a consequence the exponential spread of the virus leads to an insufficient capacity of intensive care and lab testing. Healthcare authorities and professionals are overwhelmed and at high risk. At this point only home isolation and telemedicine solutions can flatten the curve.

Fig. 1: Coronavirus COVID-19 Global Cases / March 18,2020 – 08:13 am

Hospitals and testing labs are running out of capacities

The current COVID-19 crisis hits the healthcare system which is in danger of not having enough capacity to treat health problems that are not related with COVID-19.2 A potential collapse of the healthcare system could be prevented if patients with less severe conditions can be monitored remotely in their homes. 80% of all the people going to an emergency room or seeking doctors could be monitored or treated at home to secure resources for those in urgent need.3 Already 80% of beds in hospitals are occupied by normal patients not infected with COVID-19.4

The capacity for laboratory tests must be used to the fullest possible extent for patients, doctors and nurses. On an actual data basis from telemedicine, additional ventilation and bed places, personnel requirements and expected patient numbers could be strategically planned. The idea is to make hospital admissions as organized as possible.5(Fig.2)

Fig. 2: Flattening The Curve with medical home monitoring

Medical remote patient monitoring in home isolation is the key

Patients in home isolation should be monitored for vital signs (heart rate, pulse oxygen saturation, respiratory rate, blood pressure). Throughout the home care period, daily visits or phone interviews to follow the progress of symptoms are as well part of early guidelines as the monitoring of the core body temperature multiple times daily.6

Video medicine won huge attention in the last weeks. In Germany the number of inquiries and orders increased about 60% at x.onvid for example, a telemedicine software platform – and other platforms registered increasing inquiries, too.7 Nevertheless they lack objective measurements of the required and essential vital signs and can only refer to the patients’ subjective answers. Indeed, cosinuss° can compliment these platforms with accurate, real-time vital signs data, collected continuously during the patients’ home isolation.

cosinuss° remote home monitoring solution

Fig. 3: Visualization of the home monitoring dataflow with the cosinuss° wearable, app, server and data model

Remote patient monitoring

Potential patients with low or medium risk of COVID-19 infection are required to stay at home, in isolation. These patients will each be equipped with a cosinuss° Two in-ear wearable sensor, which they should wear a minimum of 4 hours a day. The measurements will be received via Bluetooth by the cosinuss° LabApp, installed on the patient’s smartphone. The main part of the data will be processed on the wearable and the smartphone application. The pre-processed data will be streamed to the cosinuss° LabServer. This keeps the datastream in the critical IT-infrastructure slim and sleek.(Fig.3)

Vital sign analytics

All personal health data on the cosinuss° LabServer is pseudonymized. The real-time vital signs will be visualized and stored in a server database. This data is evidence for advanced early warning algorithms such as EWS or Polyscore that evaluate the urgency of intervention or hospitalization. Additionally individual thresholds on vital sign values can trigger alarm functionalities.(Fig.3)

Healthcare data access

Access is provided throughout the simple cosinuss° LabInterface that can be used by hospitals or health authorities simply using a web browser and the correct Login authorisation. Using an Application Programming Interface (API) the data can be directly integrated into Telemedicine platforms and video calls. Additionally in the future, the data can be seamlessly integrated into the databases of diverse clinical studies on COVID-19.(Fig.3)

cosinuss° components upgrade telemedicine solutions with medical home monitoring

Our company’s vision is to empower everyone in managing health without limits in location, time or number of key vital parameters to be monitored. In this sense, we are working hard to democratize fundamental health data for everyone, in the most convenient, accurate and cost-effective way.

cosinuss° Two

Fig. 4: The wearable vital sign monitoring device: cosinuss° Two

The cosinuss° Two (Fig.4) is a one-of-its-kind wearable enabling mobile medical-grade vital sign monitoring for home health use. The patented measurement technology continuously monitors 4 of the 5 key vital signs in a non-invasive way: Core Body Temperature, Heart Rate, Blood Oxygen Saturation and Respiration Rate. The cosinuss° Two combines an optical photoplethysmography (PPG) sensor8 (using standard components: LED and photo-diode), an infrared or contact temperature sensor and a 3D-axis accelerometer.

The award winning design and ergonomics are offering a high level of usability and wearing comfort. The sensor has an overall size of 45 x 38 x 18 mm and weighs 6.5 grams. The battery lasts for approximately 12 hours in case of continuous monitoring. When the person needs to be monitored in intervals, which will be the case for this application, the battery lasts much longer than 12 hours. Further technical data can be found in the data sheet.
The data science is processed directly on-board of the wearable itself, not on the server -this is called Edge Computing. This keeps the data traffic at a minimum in the whole following IT Infrastructure, which is critical to functionality in very large scale performance, as for example during an epidemic outbreak.

  • Patented measurement technology
  • Design and ergonomics
  • Edge computing data science
  • Mobile and cost-effective

The fusion of multiple stationary measurement hardware in one small earpiece without a loss of quality is revolutionary to the medical industry and is making health truly mobile and independent. A beneficial side effect of this merge is the resulting cost effectiveness.

cosinuss° LabApp

Fig. 5: Screens of the cosinuss° LabApp. Vital sign visualization, Warning Score, Telemedicine integration

The cosinuss° LabApp (Fig.5) is a smartphone application for Android and iOS downloadable from the common App Stores. It enables the smartphone to receive and store the sensor data that is transferred via Bluetooth. The LabApp itself acts as a gateway to transmit the data stream onto the cosinuss° LabServer.

Additionally the LabApp enables the smartphone to do additional DataScience and pre-processing of the data in order to keep the amount of data uploaded to the server small and sleek. The cosinuss° LabApp manages the pseudonymisation of the patients’ data and the Opt-In option of sharing his personal data for researching and remote monitoring.

The Data Visualization inside the LabApp addresses the patient himself. The objective knowledge about his current health status keeps the patient informed and confident. With the real numbers in mind he can relax and follow the guidelines of the health authorities which can be additionally communicated throughout the app. This ensures mental health throughout the stressful situation of a pandemic caused by home isolation.

  • Data Transfer
  • Data Science
  • Data Visualization

Early Warning Algorithms

As soon as an early warning score threshold is triggered the patient and the medical staff in charge will be notified throughout cosinuss° LabApp and the cosinuss° LabInterface online. Then the patient can be securely contacted and informed about the next steps, which might be hospitalization for example.

Early Warning Score

The Early Warning Score scoring system

Fig. 6: Thresholds of the Early Warning Score for each vital sign.

One solution for an early warning score system is the so-called official Early Warning Score (EWS)9. For each vital sign, the deviation from its normal range is assessed and classified into threshold ranges, with individual scores from 0 to 3, according to severity. By combining each vital sign score, a single aggregate score is eventually generated, constituting the EWS (Fig.6). The EWS itself is then classified mainly into three clinical trigger levels: low (1-4), medium (5-6) and high risk (7 or more). For example, a score of 7 indicates an increased likelihood of admission to intensive care or mortality, while a score of 4 classifies as low clinical risk.

Polyscore

Fig. 7: Comparison of Kaplan–Meier probabilities of death in the population sub-groups defined by Polyscore ≤ 2 (green), Polyscore 3 or 4 (blue) and Polyscore ≥ 5 (red). Numbers of patients at risk in the individual sub-groups are shown below the time axis

Another risk score that can be deducted from the vital signs monitor is the so-called Polyscore that has been described by medical doctors and researchers around Prof. Dr. med. Georg Schmidt, who is Head of the Working Group Biosignal Analysis and Chair of the Ethics Committee as well as one of our research partners.

“To advance non-invasive risk assessment of cardiac patients, a combination score (termed the Polyscore) of seven different cardiac risk stratifiers that predominantly quantify autonomic cardiovascular control and regulation is proposed. These risk stratification tests have previously been researched and their dichotomies defining abnormal results have been derived from previous reports. The Polyscore combination was defined as the number of positive tests among these seven risk predictors, giving a numerical scale which ranges from 0 (all tests normal) to 7 (all tests abnormal).”10 (Fig.7)

The cosinuss° COVID-19 Patient Journey using medical home monitoring

Fig. 8 Patient Journey of a medium risk COVID-19 patient in home isolation

In the first stage of awareness the patient might self-diagnose early symptoms of the Coronavirus such as cough and rising body temperature. Maybe the patient was also in contact with risk areas or persons. The first step for him would be a phone call to his doctor. In this call the risk factor of the patient will be clarified. Health authorities will be informed and the patient will be sent to home isolation at first. Here the request for the home monitoring system takes action.11

While waiting in home isolation for the opportunity to be diagnosed by a real lab test, the patients’ health insurance and health authorities are sending him the cosinuss° Two for remote patient monitoring at home. In the current urgent situation, health authorities will buy our solution and then distribute it to the hospitals, doctors, emergency healthcare professionals. Local healthcare centers will then distribute it to the people under risk and confirmed patients.

The ongoing treatment (at least for 14 days after first symptoms)10 with the doctor will then take place throughout a telemedicine application together with the LabApp monitoring integration. If the condition of the patient is evaluated critical or getting severe, which is based on the evidence of the vital signs, health authorities are notified and individual actions can be taken accordingly. This can vary between intensive home care or even hospitalization, but only if needed.

The process of recovery will keep patients loyal to the home monitoring solution in isolation. And a final release from isolation can be evidence based on a lab test and vitals sign criteria such as fever-free for 48 hours.12 (Fig.8)

COVID-19 is a call-to-action for the healthcare digitization

You would like to understand more about how your needs in fighting the COVID-19 crisis can be supported by our medical remote monitoring solutions? You conduct scientific research on COVID-19 and would like to see how our products and knowledge can help you to achieve your goals?

Contact us to receive support for our enabling technology and your pilot or research project. Our Validation White Paper and Data Sheet of the cosinuss° C-med are available on request.

Contact Person:
Dr.-Ing. Johannes Kreuzer, CEO
E-mail: info@cosinuss.com

References

  1. Coronavirus COVID-19 Global Cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU), https://www.arcgis.com/apps/opsdashboard/index.html
  2. Remuzzi, A. & Remuzzi. G. (2020): COVID-19 and Italy:what next? doi: 10.1016/S0140.6736(20)30627.9
  3. RKI https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Steckbrief.html, → 80% = mild to  moderate cases
  4. https://www.sciencemediacenter.de/alle-angebote/rapid-reaction/details/news/vorbereitungen-in-krankenhaeusern-auf-covid-19/Prof. Dr. Reinhard Busse
  5. https://www.fastcompany.com/90471598/you-can-now-get-a-free-coronavirus-assessment-online-thanks-to-
    telehealth-companies; Peter Antall, American Well’s chief medical officer
  6. Jin et. al (2020). A rapid advice Guideline for the diagnosis and treatment of 2019 novel coronavirus infected pneumonia (standard version). Military Medical Research (2020)7:4. doi.10.1186/s40779-020-0233-6
  7. Ärzteblatt, 16.03.2020: Telemedizin: Kräftiger Schub für Videosprechstunden
  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426305/
  9. Royal College of Physicians, National Early Warning Score (NEWS), 13 May 2015 (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news)
  10. Steger A, Müller A, Barthel P, Dommasch M, Huster KM, Hnatkova K, Sinnecker D, Hapfelmeier A, Malik M, Schmidt G (2019) Polyscore of non-invasive cardiac risk factors. Front Physiol doi: 10.3389/fphys.2019.00049
  11. https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2020/Ausgaben/12_20.pdf?__blob=publicationFile
  12. https://www.rki.de/DE/Content/Kommissionen/Stakob/Stellungnahmen/Stellungnahme-Covid-19_Therapie_Diagnose.pdf?__blob=publicationFile