A major risk of childbirth/surgery is the possibility that foreign objects may be accidentally left inside. Around 1 in 12 people require surgery or go through childbirth each year in the UK. Surgery is the mainstay of treatment in many health conditions such as cancer and chronic diseases and childbirth brings joy. Every year in the UK, there are around 12 million operations and 750,000 maternity events.Surgical swabs(also known as sponges) are the most common 'retained foreign object', which is also the most common procedural 'never event'. Other retained items such as needles and instruments are rare. There is good data that these events are under-reported globally due to litigation and their indefensible nature. First reported in 1884, this should simply not continue to happen in this day and age. Patients are not made aware of this during the consenting process as it is considered preventable. Retained swabs can cause extreme harm such as reoperations, severe infections, damage to organs (permanent damage in 16%, death in 5%). They can also cause cancer due to chronic irritation. The costs due to this problem to NHS amount to around £2 billion annually. Data shows that 1 in 11 procedures have counting errors and as high as 1 in 500 procedures can have a swab left inside. This is more common in complex unpredictable areas with distractions and interruptions such as childbirth and difficult operations. There is a need for a low-cost medical device to create a robust system to prevent accidental retention. We have developed a docking device that allows users to monitor swabs before, during, and after a procedure, including a method to measure blood loss. This simple, cost-effective solution with a UK IPO 'granted' patent is designed to make it impossible to leave a swab behind, vastly improving safety and efficiency. Eureka's vision is to make childbirth and surgery safer. When tested in real-life like conditions in University Hospitals, Birmingham the device system proved to be to be significantly more reliable and accurate than counting (current NHS practice).This will lower costs and reduce the need for a second checker, a practice that is prone to human error and confirmation bias. This grant will allow Eureka to collaborate with KIMAL, an established device manufacturer and Royal Wolverhampton NHS Trust, a large teaching hospital towards refinement of design towards manufacture, product development with patient and public involvement as well as real-world testing.

Surgery is the mainstay of treatment in many health conditions such as cancer and chronic diseases and childbirth brings joy. Every year in the UK, there are around 12 million operations and 750,000 maternity events. Around 1 in 12 people require surgery or go through childbirth each year in the UK. One of the risks of childbirth or surgery is the possibility that foreign objects may be accidentally left inside. This should simply not happen in this day and age. Surgical swabs are the most common 'retained foreign object', which is also the most common procedural 'never event', a severe clinical incident that is entirely preventable. Other retained items such as needles and instruments are rare. There is good data that these events are under-reported globally due to the implications and litigation, since they are indefensible. Retained swabs can cause extreme harm to patients, such as reoperations, severe infections, damage to organs, death. They can also cause cancer due to chronic irritation. The direct costs due to this problem to the NHS amount to around £2 billion annually. The childbirth and surgical environment can be complex and unpredictable, and data shows that 1 in 11 procedures have counting errors. There is a need for a low-cost medical device to create a robust system to prevent accidental retention. We have developed a docking device that allows users to monitor swabs before, during, and after a procedure, including a method to measure blood loss. This simple, cost-effective solution is designed to make it impossible to leave a swab behind. It will help staff deliver care more effectively Eureka's vision is to make childbirth and surgery safer. This grant will allow product development with patient and public involvement as well as real-world testing.

Sepsis is a life-threatening illness caused when the body is overcome by infection from pathogens such as bacteria, viruses or fungi. Sepsis has no easy detection method, but is usually diagnosed from multiple indicators. Each year there are >18 m cases of Sepsis worldwide causing 8 million deaths – equating to 1 death every 3.5 seconds (UK Sepsis Trust). Time to treatment initiation is critical for sepsis survival. For every hour undiagnosed, a patient’s mortality rate increases by 8% (UK Sepsis Trust). In the UK, it is estimated that sepsis causes 44,000 deaths each year & costs the NHS an estimated £2bn per annum (UK Sepsis Trust). As such, there is a need for healthcare providers to reduce the occurrence of incidents & mitigate costs associated with Sepsis. To enable better management of patients in emergency departments with signs of sepsis, Kimal Plc propose project to develop a wristband device capable of non-invasive monitoring of biomarkers associated with sepsis. The wristband will enable clinicians to monitor sepsis biomarkers in real-time, & provide historical tracking data to observe any decline in parameters; this will enable clinicians to modify their treatment decisions/behaviours by alerting them to worsening symptoms, allowing earlier intervention to take place. With better monitoring using the wristband & concomitant behavioural changes, it is envisaged that a reduction in morbidity & mortality will be attainable.

Sepsis is a life-threatening illness caused when the body is overcome by infection from pathogens such as bacteria, viruses or fungi. Sepsis has no easy detection method, but is usually diagnosed from multiple indicators. The mortality rate from sepsis in Europe is 36%. In the UK, it is estimated that sepsis causes 36,800 deaths each year. Time to treatment initiation is critical for sepsis survival. Mortality associated with severe sepsis is high: 30-50%. When shock is present, mortality is even higher: 50-60%. Investigators have found that for patients with septic shock, the rate of mortality increases by 7.6% for each hour that effective antimicrobials are delayed. One study of an early goal-directed treatment regimen for severe sepsis enabled a 16% absolute reduction in mortality. A recent study in Brazil determined that the occurrence rate of severe sepsis in the emergency department (ED) was 6.4% of all patients. In North American EDs, suspected severe sepsis accounts for ~500,000-750,000 visits annually, with 66-70% of patients with sepsis admitted via the ED. To enable better management of patients in EDs with signs of sepsis, Kimal Plc (KP) propose a £205,972 proof of concept project to develop a wristband & bedside display device capable of non-invasive monitoring of biomarkers associated with sepsis (Serum lactate, Venous oxygen saturation, Temperature). The wristband will enable clinicians to monitor sepsis biomarkers in real-time, & provide historical tracking data to observe any decline in parameters; this will enable clinicians to modify their treatment decisions/behaviours by alerting them to worsening symptoms, allowing earlier intervention to take place. With better monitoring using the wristband & concomitant behavioural changes, it is envisaged that a reduction in morbidity & mortality will be attainable. Patients with cryptic shock (global hypoxia but normotensive) will benefit greatly from continual lactate measurement.

Severe sepsis is a major cause of morbidity & mortality, claiming up to 64k lives/yr in the UK alone; 30-50% will die as a result of the condition. There is no reliable way to prevent sepsis, and no vaccine. The key to saving lives lies in early recognition and immediate treatment. Timely identification is therefore critical. Lactate levels in blood provide an indication of the level of sepsis in a critically ill patient. Antibiotics are used to lower lactate levels. 43% of patients die if lactate clearance takes more than 24 hours. Current treatment methodologies are time consuming (taking/analysing blood samples). This project aims to demonstrate the effectiveness of a novel type of vascular catheter technology for the measurement of sepsis through the real time detection of lactate in blood, through targeted laboratory & patient trails. This innovative on-line solution will improve treatment response times to potentially avoid detrimental impact on internal organs, benefitting patients globally.

This project will develop a multi sensor catheter initially aimed at the detection of sepsis, with further applications where the management of vital signs provides accurate diagnosis of a condition. Severe sepsis (where the body’s response to infection interferes with the function of vital organs) is a major cause of morbidity & mortality, claiming 36,000 - 64,000 lives annually in the UK. Globally, a US study estimated 3 cases to occur per 1000 population, or 20m cases per year. Because of problems with vital organs, people with severe sepsis are likely to be very ill, and approximately 30-50% die. There is no reliable way to prevent sepsis, and no vaccine. Timely identification and appropriate treatment of severe sepsis is critical. Lactate levels in blood provide an indication of the level of sepsis in critically ill patients. Antibiotics are used to lower lactate levels. Research found that over 40% of patients die if lactate clearance takes more than 24 hours. Current treatment methodologies are time consuming involving the taking and analysing of blood samples. Measurement of vital signs is mandatory for all intensive care and emergency department patients. Vital signs not only indicate the severity of illness but also dictate the urgency of intervention. The greatest utility of vital signs is their observation over time. Deteriorating vital signs are indicative of declining physiologic condition, while improving values provide reassurance. This project aims to develop a critical care catheter incorporating sensor technology to enable real time monitoring of patient vital signs without the need to draw blood samples whilst enabling the delivery of HF and other critical IV infusions. It will be specifically focused on central venous pressure (CVP), temperature and mixed venous oxygen saturation (SvO2). This project is highly innovative as currently there is no catheter on the market with a combination of sensors to measure SvO2, CVP and temperature.

Severe sepsis (where the body’s response to infection has started to interfere with the function of vital organs) is a major cause of morbidity & mortality, claiming 36,000 - 64,000 lives annually in the UK. Globally, a US study estimated 3.0 cases to occur per 1000 population per year, or 20m cases per year. Because of problems with vital organs, people with severe sepsis are likely to be very ill, and approximately 30-50% will die as a result of the condition. There is no reliable way to prevent sepsis, and no vaccine. The key to saving lives lies in early recognition and immediate treatment. Timely identification and appropriate treatment of severe sepsis is therefore critical. Lactate levels in blood provide an indication of the level of sepsis in a critically ill patient. Antibiotics are used to lower lactate levels. 43% of the patients died if lactate clearance took more than 24 hours. Current treatment methodologies are time consuming involving the taking and analysing of blood samples. Procedure states that in those with sepsis it is recommended that blood cultures be drawn before antibiotics are given, hence delaying treatment further. This project aims to develop a novel type of vascular catheter for the measurement of sepsis through the real time detection of lactate in blood. This on-line solution will remove the need to take blood samples, thereby improving treatment response times to potentially avoid detrimental impact on internal organs. As well as significant benefit to the patient (through fast and accurate diagnosis and treatment of sepsis potentially avoiding future significant health issues), this innovation will benefit clinicians by providing real time accurate information as to the condition of a patient and benefit hospitals by reducing treatment times and costs. The project is highly innovative as this design of catheter, incorporating sensors, using this type of detection method for sepsis has not been undertaken previously.