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Delivering BEACON Caresystem – a ground-breaking ICT-enabled ICU bed-side assistant providing recommenda-tions for critical mechanical ventilation support for better care and reduced costs.

Periodic Reporting for period 3 - ICU-CARE (Delivering BEACON Caresystem – a ground-breaking ICT-enabled ICU bed-side assistant providing recommenda-tions for critical mechanical ventilation support for better care and reduced costs.)

Reporting period: 2019-04-01 to 2020-03-31

In Europe 10.4% of total GDP is spent on healthcare expenditures. Of this, €350 Bn is direct hospital expenditures. In most EU Member States, hospitals are the main provider of healthcare in expenditure terms. ICUs are some of the most resource-demanding and expensive hospital units consuming 20% of all hospital costs. 1 out of 10 ICU respiratory patients are characterized as being “severe”, meaning very hard to manage and return to normal breathing. This group of patients often has an extended Length of Stay (LOS) at the ICU, making their care expensive. In fact, these 10% of patients consume 37% of all ICU costs. In addition, non-optimal ventilation and extended stays put patients at risk of lung traumas or increased mortality.

Key to reducing costs and risks is to ensure the severe patients can be safely weaned off mechanical ventilation sooner than is the case today. Why is this a difficult process? Today, a specialist doctor attends an ICU patient approx. 3 times a day. This doctor has to decide on the proper ventilation strategy in a matter of 10-15 minutes during each time. The decision – based upon a patient’s individual physiological state (i.e. cardio & pulmonary), guidelines, clinical preferences and current ventilation strategy – requires the doctor to interpret all this available information while keeping previous clinical experience in mind. But this infrequent evaluation is not optimal for the patient. Studies show that the LOS can be drastically reduced if experts oversee the ventilation management 24/7. Clearly not a sustainable solution, we see a clear need for an automated ICT approach to reform the workflow and aid the ventilation management 24/7.

We have developed BEACON Caresystem – a novel and ground-breaking ICT-based ventilation assist system, which enables better ventilation strategies and a more efficient patient care workflow. As an add-on to standard ventilation systems it provides ventilation recommendations 24/7 based on non-stop, personalised monitoring of patients. Based on unique mathematical algorithms and physiological models, it recommends weaning off scenarios, supporting the critical decision-making processes. This will especially benefit the most severe patients. Implementing the BEACON Caresystem potentially reduces the Length of Stay (LOS) with 15-25% – cutting ICU costs with the proportional amount. Looking just at critical ICU patients, this provides Europe with an annual savings potential of €3.9Bn – €6.5Bn of the €26Bn ICU cost of severe patients

To offer BEACON Caresystem commercially with the claimed value proposition of a Length of Stay reduction (LOS), our overall objective of the ICU-CARE SME project is to provide documented proof of BEACON’s LOS reduction in comparison to clinical routine. Consequently, this SME project (ICU-CARE) will seek to prepare and ex-ecute a multi-centre clinical trial of the BEACON system with a total of 500 patients. In collaboration with experts at Aalborg University (DK) and 5 hospital test sites (UK and FR), we want to:
• Validate the hypothesis of expected 15-25% LOS reduction for mechanically ventilated patients using an ICT approach
• Demonstrate ICT-enabled workflow optimization: From doctor (infrequent) to nurses (24-7)
Our overall objective in the ICU-CARE project is to clinically validate the BEACON Caresystem’s potential value proposition of 15-25% Length of Stay reduction.

The way we have planned to do this in the ICU-CARE project, is to run a multi centre clinical trial (MCCT) across 3 sites in Europe: 1 site in France and 2 sites in the UK, enrolling 500 patients totally, whereas half of the patient is being managed by BECAON and the other half being managed according to clinical practice. In this way we can measure the potential Length of Stay reduction obtained with BEACON compared to clinical practice.

In order to run the MCCT, several initial activities are required before 1st patient can be enrolled in the study. Those are:
- Draft a study protocol
- Obtain Ethical Approval for all sites
- Obtain Clinical Trial Agreements with all sites
- Manufacture and install BEACON Caresystems at all sites and perform training for all staff members including verification of usability (to make sure they know how to run BEACON)
- Initiate study and monitor enrollment, consenting, eCRF fill out etc, and then enroll first patient
The above activities have all been carried out during our first reporting period

They have all been executed on time, and for the 1st reporting period we had:
- Ethical approval for all sites
- Clinical Trial agreements with all sites
- Manufactured and installed BEACONs at all sites and trained 85% of all staff members for all sites (target was >75%) and with a usability score of 7.5 across all sites (target was >7, out of 9)
- And finally, our first patient has been enrolled in the study

Following the above activities, we have in the second reporting period executed the below activities in order to meet our objectives:
- Conduct study at Clinical sites, including supervising on patient enrolment, data collection and archiving, eCRF fill out, from patient inclusion (patient on vent) to patient completion (patient off vent).
- Collect and Analyse data from sites
- Prepare Dissemination plan

They have all been executed on time, and in addition to our RP1 objectives, we additionally have today:
- Patients are being enrolled at all sites and data are being collected and analysed
- Dissemination plan approved

So our ICU-CARE project is on time and on cost, and we have achieved our deliverables and milestones for BOTH RP1 and RP2 period as planned.
For this reporting period, limited data of the expected outcome has been generated (15-25% LOS reduction), despite the fact that we are enrolling patients, however, we have not yet enough data to be able to claim any LOS reduction

However, when the ICU-CARE project is completed, and we have proof of the LOS reduction, then the impact for society in Europe is a potential annual savings of €3.9Bn – €6.5Bn on managing patients in the ICU.
BEACON nurse and patient