Improving patient outcomes and reducing cognitive load of clinical staff in intensive care through medical-device interoperability and an open and secure IT ecosystem

Información del proyecto

SASICU

Identificador del acuerdo de subvención: 101132808

DOI

10.3030/101132808

Fecha de la firma de la CE 25 Septiembre 2023

Fecha de inicio 1 Octubre 2023

Fecha de finalización 30 Septiembre 2026

Financiado con arreglo a

• Health

Coste total

€ 17 621 997,50

Aportación de la UE

€ 8 808 922,50

Coordinado por

DRAGERWERK AG & CO KGAA
Germany

Periodic Reporting for period 1 - SASICU (Improving patient outcomes and reducing cognitive load of clinical staff in intensive care through medical-device interoperability and an open and secure IT ecosystem)

Período documentado: 2023-10-01 hasta 2024-09-30

Resumen del contexto y de los objetivos generales del proyecto

SASICU is aiming to evaluate and proof the benefits in clinical outcomes and workflow efficiency through standardized, bi-directional interoperability of medical devices based on the new standard ISO/IEEE11073 SDC. In the four different clinical use-cases together with leading European clinics and European medical technology industry, clinical decision support systems and smart alarm management capabilities are to be investigated.
While advancements in technology can offer more sophisticated treatments and new diagnosis options, the complexity for caregivers is exponentially increasing and often results in user errors, that are induced by a loss of situational awareness. To tackle this, we are developing novel systems, that channel medical device alarming information through smart algorithms to the caregivers and away from the patient bed. But we are also looking into the potential to combine gathered information in unified formats to be able to present decision support systems that are designed to lower the workload of the users, sothat they can focus on actually treating the patients.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

The work performed and the main achievements can be sectioned to the four use cases:
- Use Case #1 - Silent ICU:
The technology behind the "Silent ICU" concept, from the vendors Ascom, B.Braun and Dräger partially got launched in 2024 and first prototypical demonstrators got installed. The work in the next two project years will focus on the installation in the Erasmus MC and the evaluation. But for the technical requirements for that use case, the main step has been done.
Also for the clinical study itself, with the study design and protocol, most of the prerequisites have been completed, so that we are aiming to start with the study in early 2025.
- Use Case #2 – Smart Alarms:
Enabling smart alarm algorithms in the future, requires the new concepts and further design and development in the technological infrastructure of information systems in clinics. For that, we have designed an architecture for alarm transmission systems and remote notifying devices as well as the basic rule engine to select which alarms are relevant to the user in the actual clinical context. Next, we will further develop this system to later be able to evaluate it in first user studies.
- Use Case #3 – Smart ICU:
A PICS outpatient clinic has been opened in the Clinic in Vienna and is now building a first point of contact for patients that have stayed on the ICU previously and thus collecting data about their well-being and potential development of PICS. Additionally, the technological infrastructure, to collect medical device information of such patients has been designed and is now to be installed and included in the clinical study for further insights in the early development of PICS.
- Use Case #4 – Smart ICU:
The data collection for the first four clinical studies has been started, in order to later predict critical conditions in ICU patients e.g. with ARDS, septic shock or readiness for weaning.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

To ensure further uptake and success of the Silent ICU and Smart Alarms solutions, preliminary discussions have been made about the regulatory aspects and the commercialization strategies. To foster the adoption of the solutions in countries outside Netherlands, the relationships with Ascom’s legal entities in other regions (and not directly involved in the project) are being leveraged to gather the clinical needs of hospitals across Europe and make sure that the solutions can be adapted to specific standards of practice.

The discussions and activities related to these topics will be continued in greater detail in the second year of the project, leading to practical next steps and a list of open challenges to be solved.

Photo of consortium meeting after completion of first project year

Illustration of Silent ICU concept

Illustration of Silent ICU concept