COVID-19 is a respiratory based pandemic. With breathlessness being a vital symptom, there is no quantitative method for monitoring essential workers or the most vulnerable individuals for early symptoms. Using Spyras technology incorporated into face masks, we aim to monitor breathing pattern distress and indicate possible deterioration from COVID-19. With the predicted production volumes of face masks reaching 10 Billion in 2020 only in China(Lai Lin Thomala, 2020) and the high risk of exposure of the people using these masks to COVID-19 a means to predict possible contagion through respiratory analysis embedded within the mask becomes attractive. The benefits of wearing face mask in the fight against the virus are understood and part of clinical practice to wear, countries like Czech Republic, Morocco, and New York are making masks mandatory for the public. Personal protective equipment is a continuing limited resource. Spyras can integrate its highly accurate paper sensors into 3-ply and FFP2/3 respirator masks with minimal disruption to existing manufacturing practices by replacing the one way valves that exist. A reusable electronics would be contained within a small module that connects to the disposable mask filter and sensor. A mobile application would connect to the sensor in the mask providing respiratory analytics. This mobile app would not only gather respiratory data but also work as a symptoms tracker to monitor coughs, breathlessness and temperature when the user inputs qualitative data. Data collected through a remote app can be passed to a secure cloud platform and provide an interactive data dashboard for users to view their mask wearing and provide information on the filter efficiency and times to change to new filters to maintain filter efficiency. With funding from Innovate UK, Spyras will be able to redeploy and develop its platform from monitoring the breathing of individuals in sports and hospitals, to face masks at work or outside and take a more measured approach in their individual health profiles. Spyras can extend app features for post virus support, such as implementation of rehabilitation instruction and measures. This is to reduce the possibility of a 'second wave' of infection when restrictive measures are lifted and to assure individuals with the aftermath of such a global event. Moreover, this would positively impact the recovery of people post COVID-19. As seen from coronavirus outbreaks of the past such as SARS and MERS there will be a need for rehabilitation post healing not only for patients who have been hospitalised in ICU(Chan 2005). Extending the funding by the 'Extension for Impact' funding will significantly build on the past 3 months of work where early prototypes were placed through clinical ventilation testing to user group testing. This will be achieved by working with our chosen suppliers to produce a scalable paper sensor cartridge from the initial feasibility clinical trial to a device that can be relied upon in user trials. Having low variability between sensors and expertise in place to supply these sensors, will enable to optimal conditions for user testing.

Breathing rate has been described as the single most sensitive marker of patient deterioration (NICE, 2017). Yet, in general wards, breathing rate is only monitored through visual assessment (observing the patient from a distance and counting the rising and falling of the chest) for 30 seconds every 12 hours. As well as being time-consuming, qualitative, and highly prone to human error, several high-profile cases have highlighted that missing observations in sepsis cases have led to avoidable patient death, including babies (PHSO, 2013). Sepsis is a life-threatening condition responsible for 52,000 deaths in the UK annually (UK Sepsis Trust, 2018), second only to cardiovascular disease. Sepsis survivors often suffer from long-term mental and physical effects, including amputations, organ failure, chronic pain, fatigue and post-traumatic stress disorder (NHS England, 2015). Globally, the disease claims 6 million lives a year, including 1 million newborn babies and 100,000 maternal deaths (WHO, 2017). For every hour's delay in the treatment of sepsis, the patient's risk of death increases by 7.6% (Kumar et al., 2006), meaning that by the next observation a sepsis patient's chance of death may have increased to 50%. Yet, sepsis is a highly treatable condition if detected early. Estimates indicate that earlier identification and treatment of sepsis across the UK could save 14,000 lives annually, as well as avoid 400,000 hospital bed days, potentially saving the economy £2.8 billion (YHEC, 2017). With funding from Innovate UK, Spyras will develop an affordable, disposable wearable medical device for continuous real-time breathing analysis in general wards. Our connected device has the potential to automatically alert clinicians to patients showing early signs of deterioration. Compared to competitive devices already on the market, our paper-based sensor is lower cost and more accurate. We will demonstrate device performance in healthy subjects, ready for post-project clinical trials. As a result of late diagnosis and treatment of sepsis in UK hospitals, 59,000 patients enter intensive care units from post-operative and post-natal wards, at a direct treatment cost to the NHS of £188 million; 12,000 die during this first period of admission, while 19,400 are rehospitalised within 30 days and have long-term post-sepsis complications (Norman et al., 2017). The use of our device solely in this application could save 5,250 lives annually in the UK.