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  • Periodic Reporting for period 1 - 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.)

ICU-CARE Report Summary

Project ID: 804955

Periodic Reporting for period 1 - 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: 2018-04-01 to 2018-09-30

Summary of the context and overall objectives of the project

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)

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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 our activities planned for this reporting period (our first 6 months)

They have all been executed on time, and we have today:
- 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

So our ICU-CARE project is on time and on cost, and we have achieved our deliverables and milestones for this reporting period as planned.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

For this reporting period, limited results of the expected outcome has been generated (15-25% LOS reduction), since we have used the first 6 months of the ICU-CARE project to prepare the multi centre study (obtaining ethical approval, obtaining clinical trial agreements, manufacture and install BEACONs at each clinical site, and finally enroll first patient)

However, when the ICU-CARE project is completed, and w 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.

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