Central Monitoring in Health Care: safely detecting deterioration

To enable high acuity, continuous Central Monitoring of vital signs, with automatic triage and alarm detection. These will minimise close patient contact, reducing the risk of transmission, without missing detection of deterioration, during a pandemic and beyond. This will help Healthcare to respond to, and recover from, any future pandemics.

Dr Donald Nicolson (Primary Investigator and Medical Science Liaison at Metix Medical, Glasgow) 

The Covd19 pandemic has highlighted how common problems in healthcare are exacerbated during pandemics. Social distancing measures have been vital for reducing transmission and delaying spread (Mahtani et al, 2020), especially so because of the increased risk of infection among healthcare workers (Guan et al, 2020). But there is a risk that isolated patients, in both hospitals and the community, might be at risk from undetected patient deterioration from a long standing health condition (Willan et al, 2020). While detection of patient deterioration has improved, it remains an endemic problem in healthcare, and one made worse by a pandemic.

Adequately quantifying the scale of deterioration (during or out with a pandemic) is difficult because, depending on the condition, it can often go unnoticed (Bates and Zimlichman, 2014). Recognition of patient deterioration in acute hospital settings is poor in non-pandemic times (Treacy, and Stayt, 2019). Because of social distancing, this might have led to a greater risk of missed detection. 

Therefore the problem to solve is how to be able to capture patient vital signs, to detect patient deterioration, potentially from several patients at a time, while maintaining social distancing during a pandemic.

Our target audience are Medical and Nursing staff, in hospitals or the community. During the COVID-19 pandemic, Healthcare Professionals urgently needed to (when possible) maintain a social distance from patients who were seriously ill and highly infectious during the pandemic, to try to reduce the risk of transmission. But this could not be at the risk of missing decline in the clinical status of patients. CMHC can therefore help healthcare professionals prepare for the next pandemic. Our device and system will enable the continuous monitoring of patient vital signs, during a pandemic and beyond, when it is essential to maintain a physical distance from people who are seriously ill and still in need of urgent care. 

Our solution also serves to benefit patients who are seriously ill and still require continuous care. They might require more specialised care than normal. CMHC can track patients’ vital signs and alert staff to decline, while maintaining the patient in isolation, and therefore reducing the risk to staff and the patient.
These benefits will also serve healthcare well during non-emergency times, by normalising CMHC.

Our proposal seeks to evaluate the potential usefulness of CMHC in a high throughput area during a pandemic and beyond, to reduce the risk of transmission, without failing to detect clinical deterioration. The public good that this provides is it being a significant ‘game changer’ for Public Health. It could help prevent the transmission of infectious diseases, thereby saving lives and reducing levels of illness. Anyone who requires such healthcare at that time stands to benefit from our solution, by reducing their potential exposure to infected healthcare workers, or potentially infecting others, and by ensuring if they suddenly become seriously ill, that it will be immediately detected, enabling optimal Healthcare.

The proposed solution will benefit the “public good” in the following specific ways: Firstly, it will enhance our knowledge of how CMHC can benefit the care of critically ill people during a pandemic. This will be disseminated through a peer-reviewed publication that is Open Access. Secondly, by validating our device and system, and the process of CMHC, we will be able to provide the at-cost delivery of products, which will enhance the provision of healthcare services.

Based on interviews with Medics and Nurses, we are justified to predict tangible impact. They were impressed with running a retrospective analysis of past patient monitoring sessions for morbidity and mortality events, to identify trends and antecedents. They noted that vital signs are more reliable than notes for ascertaining if an event was preventable or not. 12 lead ECG was considered transformational. 

In particular, they thought that our high acuity, continuous monitoring device would benefit detection of deterioration, and be an essential aspect of care for COVID-19 patients, in need of continuous monitoring.

The Medics and Nurses considered CMHC could reduce continuous close contact with COVID-19 patients, and that it would have helped maintain monitoring and social distancing when there was a PPE shortage.  

Based on what they said, we can reliably imply the following tangible impacts: 12-lead ECG will have immense clinical benefit for identifying patient deterioration, detecting deterioration is essential for care of COVID-19 patients, because our device and system could benefit healthcare during a pandemic, Metix can help if there are further COVID-19 waves in the UK, COVID-19 worldwide because of varying recovery times, complications arising from COVID-19 variants, and for the next pandemic.

With support from The Trinity Challenge, Metix can evaluate CMHC and move our device and system quickly into the marketplace. By running our evaluation in the NHS, this affords us the opportunity to generate commercial interest among Clinicians, with an intention to translate into sales. 

While this has a financial benefit for Metix, and can afford potential efficiency savings to healthcare organisations, the key driver is to enable clinical benefit, by improving the detection of clinical deterioration and reducing transmission of a virus, to prevent the risk of mortality. By investing in this project, CMHC can be trialled, and we hope then implemented in healthcare in the UK and beyond, making them better prepared for the next pandemic, over the next three years. 

Other benefits for the company will be that we can grow our employment and impact on the local economy. Furthermore, the intellectual IP will be created and retained within the UK, helping to solidify the UK's leading position in the healthcare technologies sector. In the long term, we expect CMHC to be standard across the NHS, and other healthcare systems. This project will be the launchpad for this.

Evaluation runs through the heart of the proposed solution, and we will apply a range of measures to indicate the impact of our solution.

Evidence of impact will be first derived from the empirical evaluation. This includes: 1) the effectiveness of CMHC for detecting clinical deterioration; 2) the acceptability of CMHC for a range of stakeholders; 3) how reliable CMHC is for reflecting real time vital signs (no missed, incomplete, or incorrect data); and 4) how cost effective it is.

The key indicator of impact is that CMHC is realised as a way to improve healthcare in the NHS and beyond. We will measure success as the level of uptake of our device and system, if pertinent, distinguishing between times of healthcare emergencies (e.g. a pandemic), and in times of population health. This will be indicated by sales on a yearly basis. We will also measure levels of morbidity and mortality in places that have the device and system. We expect that this will be reduced by the introduction of CMHC.

Our greatest barrier is obtaining regulatory approval. We are seeking FDA approval for the USA by next January, because the regulatory landscape was uncertain in the UK for the last few years because of Brexit. We now understand the UKCA approval pathway, and will begin work in early 2022. CE marking for the EU will follow after that. 

Regulatory approval is a minimum requirement for entry to any marketplace, and has regularly necessitated drawing our staff away from other activities. But without this, we cannot do business, and so we are prepared for what is required to achieve this. 

If it becomes evident that UKCA marking will hold up the proposed solution, and we have received FDA approval, an option would be for us to work in conjunction with a Trinity Challenge Healthcare partner.

Thinking about what will be required as we move beyond the proposed work towards a solution, creating a space in the marketplace will be a challenge at first, as the medical device market is crowded. However, we have an ambitious plan of research, including this project, which will determine the benefits of our proposal, and generate an evidence-base for marketing, for the benefit of sales.

We have developed working relationships with: NHS Greater Glasgow and Clyde, Cardiff University, NHS Cardiff and Vale, and St. Davids Healthcare in the USA.

We are applying because we see our device and system as being an essential means for societies to identify, respond to, and recover from, any future pandemics. We see our device and system as a means to enable Central monitoring, being a vital tool in the arsenal of healthcare in preparing for the next global health emergency or pandemic. But we need support to enable us to realise this. 

We therefore seek funding from The Trinity Challenge to enable us to equip not just the NHS, but potentially healthcare around the world, to be better prepared for the next pandemic. The Challenge appeals to us because we see an apparent synergy between the ethos of this fund, uniting different data sources, new digital tools, public health, and science; the capabilities of our device and system; and the goals of our company. For example, by enabling Central Monitoring, we offer healthcare a template for deploying democratised cloud based monitoring with open API, for both wearable and other monitors. This agreed format for the exchange of information will improve how science can benefit healthcare in normal times and during a pandemic.

Contingent on our receiving UKCA approval, we have a specific partner identified: NHSGGC, with whom we have worked together recently on an initial evaluation of our device. We aim to run the evaluation of our solution in NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital Emergency Department in the Majors area. This is 11 spaces with a high throughput of patients with significant variation in pathology and illness severity and is therefore an excellent place to demonstrate the value of Central Monitoring of multiple patients, while maintaining safe social distancing.

However, if it becomes evident that UKCA marking will hold up setting-up, running and evaluating the proposed solution, and we have received FDA approval, the option remains for us to work in conjunction with a Trinity Challenge Healthcare partner from the USA. The problem to be addressed, and the solution proposed, would not change. This would probably require additional funding as the costs would likely be greater. But the benefits would remain the same.