Managing the huge influx of patients in hospitals is one of the most critical challenges of the current COVID-19 pandemic. Shimmer’s Bioimpedance Monitor has the potential to help manage this challenge by monitoring HR, respiration rate and depth and the increase in fluid in the lungs to triage and remotely monitor patients.
Background
Bioimpedance, specifically across the lungs, has long been studied in Chronic Heart Failure (CHF) and Acute Respiratory Distress Syndrome (ARDS). This measurement provides useful indicators of respiration, including rate, volume, and fluid in the lungs. Because COVID-19 attacks the lungs, these measurements provide clear indications of the progression of the disease. This information can be used in many ways, potentially including:
• Monitoring patients remotely at home to determine, if and when, they will need to be admitted to the hospital
• Monitoring patients in a hospital to determine when they need more aggressive treatment (e.g., ventilators)
• Enabling the earlier release of non-acute patients because of the ability to monitor at home
• Adjusting the treatment depending on the rate of progression of disease
Study Description
The off-the-shelf Shimmer3 Bioimpedance product is well suited to this task. Shimmer is an ISO 13485:2016 medical device manufacturer and this device has previously been incorporated into FDA Class II medical device. Because COVID-19 is a new disease, baseline information needs to be obtained to develop thresholds and protocols for this management. The proposed study has two arms: In-Hospital Monitoring (50 participants) and Remote Monitoring (250 participants). We believe this program can be completed in under two months.
Shimmer is currently seeking sponsors for the research study. A more detailed project outline is available on request.
Implementation Preparation
This research project is just the beginning. The results will be incorporated into a protocol to use this information in clinical practice. In parallel to the research study, Shimmer is preparing to support wide deployment of the devices, including integrating the device into EHR or other clinical management systems and preparing to ramp up production to the required levels. Shimmer’s parent company is an ISO 13485:2016 certified contract manufacturer, so it will be possible to ramp up to 30,000 – 50,000 units per month in ~2 months.
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