Title: Continuous respiration monitoring using a novel, wearable capaciflector sensor for early detection of distress, enabling quicker intervention for improved patient outcomes.
Funder: Department of Health and Social Care

Abstract: Respiration rate is the only vital sign that is not routinely measured continuously, but It is an effective early indicator of patient deterioration. We have developed a novel type of respiration sensor that uses a new measurement principle, comprising a low-cost, simple sticker attached to the chest and can wirelessly transmit data to a remote base station. The project aims to develop a user-friendly system, validate the technology in real-use scenarios and demonstrate value to the NHS in terms of identifying early decline in patient health, which can be acted on to improve patient outcomes. Public and patient involvement is very important to this project as the device will be a wearable sensor and therefore acceptability for both patients and clinicians is required. Sensor optimisation will be obtained using advanced modelling techniques, which take into account the constraints of mass production. The miniaturised electronics and real-time, advanced signal processing techniques will be developed and wireless protocols will be established so that many sensors (one per person) can be monitored simultaneously. Motion artefacts will be eliminated through machine-learning techniques and integration with inertial sensors (accelerometers and gyroscopes). A concordance study against gold standard plethysmography will be performed for a broad range of patients (age, sex, medical condition), both in static and ambulatory situations. The technology will be evaluated on patients in acute settings with the aim of developing a package of evidence to support the patient-and cost-benefits of the technology. Hospital in-patients will be monitored continuously during their stay and the data collected will be compared with their periodic routine NEWS 2 scores to identify early indications of respiratory distress. Successful impact of this project is that all in-patients can be monitored continuously and the system will give early, but precise indication thereby allowing early intervention and potentially saving lives.

Lay abstract: Background to the research Changes in breathing rate are the single earliest sign of patient deterioration in a number of diseases including sepsis and also COVID-19. These almost always precede changes in other vital signs. Every year, thousands of lives are lost due to sepsis and late detection of respiratory disease. The earlier these changes are detected, the more effective the treatment. This can therefore reduce deaths through early targeted intervention and is hence an NHS priority. Chest-band or facemask systems are available for measuring respiration rate continuously but are uncomfortable for use over long periods of time (more than an hour). Aims and methods Respiration rate is the number of breaths per minute. A changing rate is one of the earliest signs of patient deterioration in many diseases. Currently, in hospitals, this is measured by nurses manually counting the number of breaths taken in a minute. It is measured every 4-6 hours, which introduces delays in detecting changes in respiration rate and potential treatment. The aim of this project is to deliver a wearable system that can continuously and accurately display readings and warn clinicians of changes in respiration rate that indicate patient deterioration. The system will also display a profile history of respiration rates to allow longer-term trends to be monitored. The device will be a mass manufacturable, low-cost electronic 'sticker' that wirelessly interfaces to a remote smartphone/tablet. This project will involve clinicians, engineers and public/patients to develop technology (hardware and software), for a new type of respiration sensor, which is comfortable to wear for many days. Data will be displayed on a dedicated smartphone app to the healthcare team, who can use the device as an early warning system and respond promptly. The project will also provide a route to achieve regulatory approval for use within the NHS. The funding will facilitate the formation of a commercial pathway for mass-production of the complete system and allow also intellectual property to be protected. Patient and public involvement (PPI) For a wearable device, it is essential that the public and patients have early input into this project in order to achieve a wearable device with optimal technical performance. PPI will be therefore an ongoing activity throughout the project. In March 2020, we discussed and evaluated early prototypes with six former Southampton Hospital patients, who showed enthusiasm and support for our device and provided excellent feedback regarding its perceived value to patients, wearability, accuracy and cost. We will adopt a variety of dissemination activities including scientific publications and attendance at commercial exhibitions. There will also be a broad engagement to ensure that the general public is aware of the developments and that routes to the NHS marketplace are fully established.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: RESPIRATORY