Community Research and Development Information Service - CORDIS

H2020

PREPARE Report Summary

Project ID: 711269

Periodic Reporting for period 1 - PREPARE (Preventing Respiratory Events through Proactive Assessment of Respiratory Effort)

Reporting period: 2016-04-01 to 2017-01-31

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.

With Chronic Obstructive Pulmonary Disorder (COPD) being the 2nd biggest cause for hospital emergency admittance and it growing to be the 3rd biggest killer by 2013.

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

During the first 10 months of the PREPARE project, PMD has grown its multidisciplinary research team, established an international business development team, and expanded the compliance team. As a result of this investment, PMD has created revenue, gained support by the SBRI division of the NHS England, secured distribution contracts for both products, and established several internationally based centres of excellence for clinical research which include countries such as England, Denmark, Wales, and Ireland.

This early success has been attributed to the development of a strong technology and marketing foundation. Over the past 10 months, PMD has invested in its online presence in terms of website and social media interactions. Combining engineering and marketing, PMD has also completed market research on its consumer sleep product - sleep3z, a consumer 3-night sleep assessment tool. Designed to address the exponential increase in the awareness of sleep apnoea. A condition costing the US alone $34bn per year from delayed diagnosis and treatment. This societal need is also driving the advanced research in screening solutions for dysfunctional breathing.

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)

PMD is revenue generating, with growth expected as PMD prepares to enter the USA in Q4 2017 on the anticipated receipt of approval from the FDA. Together this growth trajectory is compounded by the planned release of the companies sleep product range, and entry into the consumer sleep wellness market.

PMD Solutions’ ambition is to improve patient outcomes by making every breath count. PMD plans to achieve this through several clinical investigations to 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.

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.

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