The Oxygenation Module - The Missing Link in Using Sleep Apnea Devices to Treat COVID-19 Pneumonia at Home

Abstract

Background: The study aims at solving the problem with the limitations of the homecare CPAP equipment such as sleep apnea devices in the treatment of COVID-19 pneumonia. By adding an advanced, rapid-to-produce oxygenation module to CPAP device we allow distributing healthcare at all levels, reducing the load on intensive care units, promoting treatment in the early stages at homecare. A significant part of the COVID-19 pneumonia patients requires not only an oxygen supply but also additional air pressure. Existing home care devices are able to create precise positive airway pressure but cannot precisely measure supplied oxygen concentration. Either uses uncertified and potentially unsafe mechanisms.Results: The developed system allows using certified and widely available CPAP (constant positive airway pressure) devices to perform the critical function of delivering pressure and oxygen to airways. CPAP device is connected to the designed add-on module that can provide predefined oxygen concentration in a precise and stable manner. Clinical test results include data from 12 COVID-19 positive patients. The device has been compared against certified NIV (non-invasive) equipment under 6-20 hPa pressure and 30-70% FiO2. Tests have proved that the developed system can achieve the same SaO2 (p=0.93) and PaO2 (p=0.80) levels as NIV with clinically insignificant differences. Test results show that the designed system can substitute NIV equipment for a significant part of COVID-19 patients while leaving existing NIV devices for unstable and critical patients. The system has been designed to be mass-produced while having medically certified critical components.Conclusion: The clinical testing of the new device for oxygen supplementation of patients treated using simple CPAP devices looks promising and could be used for the treatment of COVID-19 pneumonia.