DELIRIUM
acute brain failure can be measured with EEG

Delirium, a high incidence, serious and costly complication

Delirium is a manifestation of acute brain dysfunction, defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) as: “a disturbance in attention and awareness that develops in a short period of time, fluctuates, and is accompanied by a change in cognition”.
It is the most common surgical complication amongst older adults, but it can occur in patients of any age.

All delirium guidelines state and many research publications show that: 
– early detection is poor and most cases are missed;
– prompt diagnosis of delirium and timely treatment of the underlying causes are important for reducing the severity and duration of delirium and risk of complications from it.

To improve delirium detection & monitoring, the research & development leading up to the EEG based DeltaScan was initiated by UMC Utrecht. The need for an objective & practical device for routine hospital care was identified and it resulted in DeltaScan.   

 

The DeltaScan project.EU is defined in several Work Packages:

WP1: DeltaScan product completion and regulatory approvals
Pre-commercial DeltaScan Monitor and electrode Patch will be manufactured and CE certified.
Commercial DeltaScan Monitor and Patch will be developed, CE certified and FDA approved.

WP2: Clinical Evaluation Program of DeltaScan with a key role for the 4 Consortium Partners
This Program (shortly named CLEO study) is designed to evaluate the clinical benefits of the use of DeltaScan in routine clinical practice in European ICUs and general wards (clinical evaluation no. 1 and no. 2), compared to the delirium care as usual. Most important expectations are more detections, earlier detections; and, consequently, a reduction of the duration of hospital stay, and a linked reduction in direct medical costs.

WP3: Commercial and Organizational readiness
This work package is all about making Prolira ready for full-scale commercial launch and maximizing Prolira’s growth potential, so that DeltaScan is made available to hospitals in Europe, benefiting the patients, nurses and doctors, hospitals and society.

WP4: Dissemination and communication
This work package fits with the EU’s and our consortium’s wish for Impact. We have the goal to improve delirium care. For that we also have to raise delirium awareness and continuously stress the importance of early detection and objective monitoring. Our DeltaScan technology finally enables that. Therefor we will have to reach as many users, buyers and key influencers with the right messages, as possible. The main objective is to conduct dissemination activities to support the consortium’s strategy to make DeltaScan the Gold Standard, and the preferred solution for delirium monitoring. We believe this is best communicated through different channels: scientific publications, presentations in clinics, on congresses, commercial ads, and to the wider public.

WP5: Project management
This Work Package covers all project management and organizational aspects with the following objectives:
-Organization of a project kick-off meeting with all Consortium Partners
-Project and stakeholder’s management to ensure the overall objectives of the project are met
-Effective coordination and use of project resources (incl. financials)
-Collation of accurate reports for each reporting period (incl. accounting)
-Liaison with the European Commission

Prolira B.V.
Padualaan 8
3584 CH Utrecht
The Netherlands

tel: +31 (0)6 2297 8972
info@prolira.com