Impact case study database

The research led to the development of novel algorithms for the non-invasive extraction of physiological indicators to help clinicians and nurses intervene swiftly and save lives. All Aston algorithms are now embedded in Isansys’s Patient Status Engine (PSE) – the WoB algorithm is subject of forthcoming clinical trials.

The methods and techniques Aston developed were tested on real data from 982 patients provided by Birmingham Children’s Hospital (BCH) in 2018/19. All data were provided with reference values against which the extracted measures were checked.

The results [ R4, R5] proved to be more accurate and reliable than those previously recorded by Isansys’s devices, achieving 99.8% accuracy in QRS detection, 81% accuracy in the WOB estimation and a mean absolute error (the mean error between the actual and estimated values) estimation of just 0.4 in the breathing rate.

A Consultant from Birmingham Children’s Hospital’s Paediatric Intensive Care Unit, said: “This technology is truly transformational. For the first time it allows us to analyse patients’ data in real time in the same way that various other high risk industries have done for years.” [ S1, S2]

Because the algorithms obtain the measures non-invasively by analysing a hospital patient’s routinely monitored ECG signals [ R3, R5], they reduce patient discomfort and the number of sensors required. Through the Paediatric Early Warning Score (PEWS) they also enable health professionals to be alerted quickly to potential issues.

The Consultant said: “The ability to track and identify deterioration towards a cardiac arrest will give doctors the chance to save the patient’s life.” [ S3]

The algorithms have had the following impacts:

• The algorithms have been embedded in Isansys’s PSE, improving the quality of the company’s medical devices [ S3] and particularly their ability to measure respiration rate. The Isansys Chief Executive, said: “Respiration rate is a difficult vital sign to measure accurately. We are therefore very pleased to report that one of the early outputs from the ECG-Derived Biosignals project was an improvement to our current method of deriving respiration rate… Feedback from other users has been very positive and no issues about the accuracy of the respiration rate functionality have subsequently been recorded in our post market surveillance reports.”

• The algorithms have also led to the Isansys PSE’s FDA certification for commercial exploitation in the US [ S4]. The CEO of Isansys said: “Since the inclusion of these Aston developed improvements to the algorithm in the PSE, we have been able to meet the rigorous requirements of the US FDA 510(k) procedure and as a result the PSE is now certified for commercial exploitation in the USA.”

• The algorithms have now led to pending clinical trials of Aston’s novel Work of Breathing (WOB) measure (currently on hold due to the COVID-19 pandemic). Monitoring breathing distress is currently invasive and expensive, so a clinically-proven, automatic WoB measure derived from ECG signals would reduce treatment costs and the number of staff required to monitor patients. The CEO of Isansys said: “We expect the new automatic WOB (Work of Breathing) measure … to yield very promising results. Trials were envisaged to commence at Birmingham Children’s Hospital to enable the earlier detection of potential life-threatening adverse events using real-time data, instead of relying on post processing of lab test and other data held in the patient’s electronic medical record… Isansys intends to undertake these trials with existing hospital customers both in the UK and overseas. However, all planned studies are now on hold as a result of the Covid-19 pandemic.” [ S4]

• The algorithms and their incorporation into Isansys’s devices could have huge commercial implications. The CEO of Isansys said: “Ideally, every patient in hospital would be continuously and automatically monitored. In practice hospitals deem around 60% of their patients need to be monitored in this way. For the UK alone, this figure is around 12 million patients annually and globally hundreds of millions. The total patient monitoring market is therefore many £billions and the market leaders will be those companies whose systems and devices provide the most accurate and trustworthy data. The ECG-Derived Biosignals project with Aston University will stand us in very good stead to maintain a leading position.”

Aston’s algorithms and alarm system are also integrated into Isansys’s wireless Lifetouch device, which connects to the PSE. This wearable device can be attached to the chest and ankle to measure and analyse vital signs in real time. This kind of non-invasive, individual monitoring provides real-time accurate information about the patient, potentially leading to faster treatment, lives saved and reduced hospital stays. The mother of one of the patients said: “I’m so pleased that [my child] was able to take part in the study. I think the wireless technology is great, I can pick him up more easily and he is constantly monitored [ S1].”