Sensium: Early Detection of Patient Deterioration (#2673)

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Idea Description
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Innovation 'Elevator Pitch':
Sensium accurately & reliably monitors & transmits patients’ vital signs every 2 minutes & notifies of deterioration between Observation rounds. Easy to use, SensiumVitals provides tangible benefits for patients, clinicians & for the hospital.

Overview of Innovation:
In general care areas of a hospital vital signs are typically taken during routine observation rounds once every 4-8 hours. If a patient deteriorates between these observation rounds the warning signs can go undetected for hours, potentially leading to serious & costly consequences.

Sensium is a discreet, wearable, wireless system for monitoring vital signs of patients outside of high acuity areas. A light comfortable sensor worn on the patient’s chest accurately & reliably monitors & reports vital signs providing data every 2 minutes. By notifying clinicians of changes in patients’ vital signs Sensium brings the nurse to the deteriorating patient. This includes patients on general wards, post-operative med/surg. wards & patients waiting before & after treatment in A&E departments.

Sensium Patch provides accurate & continuous monitoring of the 3 key leading indicators of patient deterioration: heart rate (HR), respiration rate (RR) & axillary temperature (T). Sensium wirelessly communicates this physiological data via safe & secure low power wireless communication to the Sensium bridges placed through the ward area.

The bridges are connected into the hospital IT system, & software installed on the hospital network allows patient data to be seamlessly conveyed. Crucially, notifications can be configured to work with hospital pager systems/mobile notification devices, giving the clinical team data when they need it, where they need it. To save time & ensure accuracy Sensium can be easily integrated with the hospital admission, discharge, transfer systems & electronic medical records.

Sensium allows patients to ambulate freely, untethered to static & expensive equipment whilst still having the reassurance of continuous monitoring.

The 3 most serious, costly & avoidable care incidents in unmonitored patients are: Sepsis, Cardiac arrest, Respiratory depression.
  • In Britain more than 100k people suffer from severe sepsis each year. 37k of them will die from the disease. Each case of severe sepsis costs the NHS £20k meaning treatment costs £2bn a year.
  • There are approx 25,428 in-hospital cardiac arrests in the UK per year. More than 80% of hospitalised patients who suffer a cardiac arrest do not recover.
  • 1 in 100 patients treated with opioids for moderate to severe post-operative pain will experience events related to respiratory depression. 17 In the UK there are approx 7m operations performed each year resulting in a potential 70k cases of respiratory depression.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
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Innovation 'Elevator Pitch':
Sensium Wireless Vitals Monitoring is proven to lead to treatment of sepsis 6 hours quicker than NEWS, reduce LOS by 10% and readmission by 45%. The only wearable vital sign monitor with peer reviewed RCT data showing significant clinical benefits. 
Overview of Innovation:
In general care areas of a hospital vital signs are typically taken during routine observation rounds once every 4-8 hours. If a patient deteriorates between these observation rounds the warning signs can go undetected for hours, potentially leading to serious & costly consequences. 
 
Sensium is a discreet, wearable, wireless system for monitoring vital signs of patients outside of high acuity areas. A light comfortable sensor worn on the patient’s chest accurately and reliably monitors and reports vital signs, providing data every 2 minutes. By notifying clinicians of changes in patients’ vital signs Sensium brings the nurse to the deteriorating patient, allowing intervention before the condition worsens, thereby improving patient outcomes, shortening hospital stays and lowering treatment costs. It enables nurses to prioritise patient care where it is needed most.   Sensium is focussed exclusively on general care clinicians whose patients currently do not have the safety and security of continuous vital sign monitoring.
 
The Sensium Patch provides accurate and continuous monitoring of the 3 key leading indicators of patient deterioration: heart rate (HR), respiration rate (RR) & axillary temperature (T). Sensium wirelessly communicates this physiological data via safe and secure low power wireless communication to the Sensium bridges placed through the ward area.  Sensium allows patients to ambulate freely, untethered to static and expensive equipment whilst still having the reassurance of continuous monitoring.
 
The bridges are connected into the hospital IT system, and software installed on the hospital network allows patient data to be seamlessly conveyed. Crucially, notifications can be configured to work with hospital pager systems/mobile notification devices, giving the clinical team data when they need it, where they need it. To save time and ensure accuracy Sensium can be easily integrated with the hospital admission, discharge, transfer systems and electronic medical records.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Digital health / Innovation and adoption / Patient and medicines safety
Benefit to NHS:
Currently approximately 10% of patients are harmed during their hospital stay and this represents a cost to the NHS of over £2.5bn just to cover the additional length of stay for these patients. Improved monitoring regimes and early detection of deterioration is key to reducing this significant burden.
 
Patients undergoing major abdominal surgery have an 30-40% risk of complications with a leading complication being sepsis. Hospital acquired (HA) sepsis (e.g. sepsis that develops after a surgical procedure) has twice the mortality rate and twice the treatment cost of community-acquired sepsis and rates of HA sepsis are rising. A recently-published study aimed to assess differences in outcomes between patients being monitored using the Sensium system in addition to intermittent (routine) observations and patients being monitored by routine observations alone [1].  The study was designed as a pilot cluster-randomised, prospective, parallel-group, controlled single-centre pilot study and consenting participants were allocated to one of two monitoring arms for the length of their admission. The primary outcome measure was time to antibiotics after the first evidence of sepsis, defined according to a revised consensus conference definition in 2001 [2]. Secondary outcome measures included length of hospital stay, 30-day readmission rate, mortality and patient acceptability. 226 patients were randomised between January and June 2017. 140 patients were randomised to continuous remote monitoring; 86 patients were randomised to receive intermittent monitoring alone. There were a similar number of complications and sepsis events across both arms of the study, indicating that both groups had similar baseline risk factors.

On average, patients receiving Sensium continuous monitoring were administered antibiotics 6.4 hours sooner after evidence of sepsis, had a 10% shorter average length of hospital stay and were 45% less likely to require readmission within 30 days of discharge than those patients in the intermittent monitoring group. Patients found the monitoring device to be acceptable in terms of comfort and perceived an enhanced sense of safety. Given that every hour’s delay in treatment of sepsis has been shown to be associated with a 7% increase in risk of mortality [3], a 6-hour reduction in time to administer antibiotics is a significant result and further studies are ongoing to demonstrate similar benefits in other clinical settings.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Sensium’s solution offers several key benefits to the West Midlands and its population. The key benefits of Sensium compared to competitor products are as follows:

Product Performance: Sensium uses clinically accepted ‘gold standard’ methods of vital sign measurement, deriving heart rate from single-lead ECG, respiration rate from thoracic impedance, and temperature from an axilla sensor.  In contrast, our competitors derive respiratory rate from pulse or ECG measurements which has known limitations in certain clinical conditions and provide only skin temperature measurement which has limited clinical value.

Customer Focus: Sensium is recognised by our customers for exceptional customer support.  Once we deploy our product at a clinical site, we provide on-site technical support for installation and troubleshooting and clinical support for training for as long as it takes for the system to be truly embedded in the clinical workflow and providing tangible benefits. Sensium has clinical and technical staff based in the West Midlands region on hand for support.

Clinical Evidence: Sensium understand that medicine is an evidence-based science and we are engaged in a series of clinical research studies designed to show clinical efficacy, improved clinical outcomes, and health economic benefits.  To date, Sensium are the only company providing wearable wireless technology for early detection of patient deterioration that have independent and peer-reviewed publications showing benefits of our technology demonstrated through randomised controlled trials
 
 
Current and planned activity: 
Our initial engagement with the NHS has been to introduce Sensium to general surgery wards and areas with high risk and infection prone patients e.g. colorectal, trauma and haematology wards. Discussions with many NHS hospitals have also shown significant interest and benefit for the use of Sensium for ‘Step down’ areas for patients who aren’t sick enough for ITU but still show cause for concern and for high risk conditions such as Hospital Acquired Sepsis opioid depression and AF. 

We have engaged with the Emergency Laparotomy Collaborative with a view to patch these types of patients. When approaching the NHS, we have been primarily engaging with Anaesthetists as they witness many patient deteriorations, as well as consultants and sepsis/patient deterioration leads, matrons and clinical IT leads. We plan to interact more directly with medical directors and members of the directorate earlier on in the process if possible. Future plans include home monitoring to follow patients’ home.
What is the intellectual property status of your innovation?:
CE mark and FDA 510(k) cleared.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
N/A
Ease of scalability: 
2
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Innovation 'Elevator Pitch':
RespiraSense demonstrated a potential for 6-12 hours earlier detection of patient deterioration when compared to the standard of care. Putting that into context, for every 30-minute delay in treating Sepsis, increases the risk of mortality by 7%.
Overview of Innovation:
RespiraSense is the world's only continuous respiratory rate monitor. Respiratory rate is the earliest and single most sensitive indicator of patient deterioration, more so than heart rate if systolic blood pressure. In fact, 26 breaths per minute are considered the earliest point of divergence between Spo2 and respiratory rate. Giving rise to 12+hours of false security is accurate RR is not measured. 

The standard of care remains the manual counting of breaths per minute, which has been shown to be biased and prone to error. With evidence showing no change in the quality of measurements for over 170 years (1846SirHutchenson) (2017Badawy). 

RespiraSense gives medical teams the advantage of being able to intervene early, thus reducing time to intervention and improving outcomes. Outcomes such as Average Lenght of Stay, Average Unit Cost of Care, and Patient Safety targets can be achieved. 

RespiraSense is a simple, wireless, and discrete wearable monitor, placed on at admission and worn/measuring continuously for upto 7 days. Each patient recieves a new sensor and a reusable electronic device or Lobe. See how the system works @ 
https://www.youtube.com/watch?v=u6KB1hBPQbM​ 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Wellness and prevention of illness / Education, training and future workforce / Wealth creation / Clinical trials and evidence / Digital health / Innovation and adoption / Patient and medicines safety / Person centred care
Benefit to NHS:
Each year, there are approximately 500,000 admissions of Sepsis and Pneumonia with an average unit cost of £4,600 per admission. These two conditions are increasing in incidence and oftentimes lead to an escalation of care due to the risk of undetected deterioration. It is shown that a 5% reduction in the escalation of care of these two pathways alone, through the use of continuous Respiratory Rate monitoring triggering decreased time to interventions (Fluids, Oxygen, Antibiotics, Steroids), can reduce the average unit cost by £300 and the average length of stay by 0.5 days. This translates into a total Net cash saving of £115m and 250K bed days. Popular opinion suggests that as high as 20% reduction is achievable - Evidence pending. 

Each event prevented, having an average cost of £25,000, will pay for a whole year's supply of sensors for one year. 
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
West Midlands Trusts are driving the awareness of Sepsis through their ambulance services, patient awareness campaigns, and in-hospital initiatives. With 44,000 lives lost each year attributed to Sepsis, it is important to Prevent, Diagnosis Early, and Effectively Treat the condition. RespiraSense focused on the area of Diagnosis Early. Research suggests that NEWS2 is a more sensitive indicator of deterioration due to Sepsis than QSOFA. Both of which have Respiratory Rate as a key parameter to measure. There is clearly value in monitoring this essential vital sign accurately, and clear additional benefit to having it monitored continuously. RespiraSense achieves both with low impact of False alarm due to its innovative design, boasting advanced motion-tolerance. 
Current and planned activity: 
PMD Solutions is working with Nursing Times to launch an educational campaign on the clinical science and importance of respiratory rate monitoring in acute care clinical practice. 

In addition, PMD Solutions is looking for Respiratory and Emergency teams to partner with and create a culture of Peer Leadership in the development of best practice for respiratory rate monitoring. 
What is the intellectual property status of your innovation?:
RespiraSense is positioned to be the new industry standard in respiratory rate monitoring. It is patented in Europe, United States, China, Hong Kong, and Japan. 
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
2
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