Preventing Respiratory Events through Proactive Assessment of Respiratory Effort

Project Information

PREPARE

Grant agreement ID: 711269

DOI

10.3030/711269

Project closed

EC signature date 17 March 2016

Start date 1 April 2016

End date 30 September 2018

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 4 265 610,00

EU contribution

€ 4 265 610,00

Coordinated by

PMD DEVICE SOLUTIONS LIMITED
Ireland

Periodic Reporting for period 3 - PREPARE (Preventing Respiratory Events through Proactive Assessment of Respiratory Effort)

Reporting period: 2017-12-01 to 2018-09-30

Summary of the context and overall objectives of the project

PMD Solutions (PMD) is a medical device company that is improving patient outcomes by making every breath count. As part of the H2020 project PREPARE (Preventing Respiratory Events through Proactive Assessment of Respiratory Effort), PMD is internationalising its RespiraSense product as an industry standard for respiratory rate monitoring and elevating the state of the art for preventive care models. RespiraSense is a solution that can reduce patient events by indicating early signs of patient deterioration. PMD is also developing its novel sensor platform for applications in population sleep screening and as a tool for assessing changes in dysfunctional breathing.

Respiratory rate is an essential vital sign, like heart rate and blood pressure. It’s the body's way of controlling the amount of oxygen in the body. Significant research has shown that respiratory rate is an early predictor of events such as cardiac arrest, sepsis (blood poisoning), and respiratory compromise. All of which can lead to a patient hospital bound from 5 to 26 days if interventions are delayed. Respiratory rate of 27 breaths per minute has been shown to be the earliest and most sensitive indicator of cardiac arrest, while sepsis and respiratory compromise have indicators of 22, 24, and 30 breaths per minute.

To put this into context, a study by Cretikos et al. (2007), found that just over half of patients experiencing a serious adverse event, such as cardiac arrest or ICU admission, on general wards had a respiratory rate greater than 24 breaths per minute. These patients could have been identified as high-risk up to 24 hours before the event with a specificity of over 95%.

However, it has been found that respiratory rate is the one observation which nursing staff recorded less than 50% of the time (Hogan 2006) and quite often respiratory rate measurement is omitted even when the patient's primary problem is a respiratory condition (Cretikos et al. 2008). This is largely due to no accurate and reliable technology being available for measuring this important vital sign, resulting in subjective and intermittent manual counting and recording.

PMD has developed a revolutionary new approach to respiratory monitoring that enables continuous respiratory rate monitoring from when a patient is admitted to when they are discharged. PMD proposed that through the use of RespiraSense, that the 20% of patients having a breathing rate of 25-29 breaths per minute, who would have deteriorated or died, can not only be identified but given timely interventions to prevent such events. The result, each event costs on average €28,000 with an addition seven days length of stay. Timely interventions will reduce both the operational and economic burden on a hospital while improving the quality of care and quality of life for the patient. Both in the short and long term, as events in hospital, have a profound impact on a person's life.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

PMD has now completed the PREPARE project, which lasted a total of 30-months. Throughout this period, PMD achieved its target objectives and milestones as planned. PREPARE enabled PMD to grow its multidisciplinary research team, establish an international business development team, and an expanded compliance team. This generated revenue, gaining support from the SBRI division of NHS England, secured distribution contracts for both products, and established several internationally based centres of excellence for clinical research throughout Europe, including countries such as Denmark, Wales, Ireland and England.

A significant achievement during PREPARE was earning CE Mark Certification for RespiraSense and the RespiraSense Apnoea Screener, which enables PMD to sell these products within Europe as there comply with health, safety and environmental protection standards. PMD developed a consumer sleep product - Sleep3Z- in September 2017. This tool is designed to exploit the exponential increase in the awareness of sleep apnoea amongst the general population, a condition which has wide societal impacts in regards to lost productivity, traffic accidents and being attributed to increasing the risk of hypertension and heart failure.

Clinical investigations were completed at four sites across Ireland, Wales, England and Denmark and results are positive. Papers have been authored for each study and have been submitted to open access peer review journals for publication. To date the results of a study which demonstrate the accuracy and motion tolerance of RespiraSense has been published in Sensors (Subbe, 2018). PMD are now preparing for USA entry in 2019.

PMD has continued to invest in its online presence in terms of website and social media interactions to grow dissemination activities throughout 2017 and 2018. There have been a number of noteworthy press releases including one which disseminated the fact that PMD has been selected as an innovative respiratory device leader to join the NHS Innovation Accelerator (NIA) Programme in the UK. The NIA is an NHS England initiative delivered in partnership with England’s 15 Academic Health Science Networks and focused exclusively on identifying and partnering with only the top leading healthcare pioneers in the market. Since its launch in July 2015, the NIA has supported the uptake and spread of 25 high-impact, evidence-based innovations across 799 NHS organisations.

PMD has presented and exhibited a range of conferences and trade fairs including MEDICA, the largest medical trade fair in the world, featuring more than 5,100 exhibitors from 70 counties as part of the Enterprise Ireland delegation at the event.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Revenue growth is expected to grow in 2018 and 2019 as PMD works closely with European and Asian markets.

PMD Solutions’ ambition is to improve patient outcomes by making every breath count. PMD plans to continue with its clinical investigations which bolster not only the technology’s accuracy and robustness but to also demonstrate its ability to transform patient flow by triggering more early interventions and reducing the cost of care for both hospital and patient. PMD claims that by 2020, RespiraSense will have saved European healthcare systems €775 million by reducing adverse events, reducing the length of patient stay, reduce preventable intensive care admissions, and improve the quality of life for patients.

An output of PMDs clinical investigations has shown motion-tolerant respiratory rate monitoring, this is something that no other manufacturer has achieved. Following on from the success of achieving CE Mark certification this year the next step of submitting to the FDA for USA regulatory approval will be a major milestone in PMDs plans to be the industry leader in this area by 2020.

References
Cretikos, M., Chen, J., Hillman, K. The objective medical emergency team activation criteria: a case-control study. Resuscitation. 2007;73:62-72.
Hogan, J. Why don’t nurses monitor the respiratory rate of patients? British Journal of Nursing. 2006:15(9);489-492
Cretikos, M., Bellomo, R., Hillman, K., Chen, J., Finfer, S., Flabouris A. Respiratory rate: the neglected vital sign. Medical Journal of Australia. 2008;118(11):657-659.
Subbe, C.P Kinsella, S.H. Continuous Monitoring of Respiratory Rate in Emergency Admissions: Evaluation of the RespiraSense™ Sensor in Acute Care Compared to the Industry Standard and Gold Standard. Sensors 2018;18:2700.

PMD's RespiraSense product