Safe Brain Initiative, Operationalizing Precision Anaesthesia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Southern Denmark

About this trial

Perioperatively, patients experience an unnecessarily high level of side effects associated with their treatment. These side effects include nausea, severe pain, anxiety, and stress. Moreover, many patients develop postoperative delirium (POD) and neurocognitive dysfunctions, often resulting in long-term cognitive impairment, decreased quality of life, and increased mortality. However, physicians, nurses and their institutions do not receive structured feedback regarding these aspects of each patient's well-being. They may therefore be unable to engage in the essential cause-and-effect learning necessary to evaluate and consecutively reduce such side effects.

Effective guidelines conform prevention is the proven key to shielding our patients from adverse Outcomes. The Safe Brain Initiative's high-quality routine data-for-action is a sword and accelerator for moving towards patient-centred, precision care. Thus, establishing a foundation for value-based and patient-centred healthcare development.

However, a turnkey real-world solution is challenging to develop and implement and requires substantial resources. As a result, such solutions are usually beyond the scope of a single institution. The SBI platform provides high-quality, real-world data to bridge this gap. It allows monitoring and in-depth analysis of cause and effect in the day-to-day routine of individuals, departments, and institutions.

The SBI's approach is continuously improved and updated. An organization called the SBI Global Society oversees the quality and precision of science through experts in the field. At SBI Hospitals and Flagship centres, Masterclasses are conducted and can be attended alongside clinical immersions.

SBI Solutions manages, develops, and provides technical and service support for the Safe Brain Initiative. Its service guarantees the professional and GDPR conform management of data handling and storage as well as the user-friendly functionality of the SBI-Dashboard solutions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

• All surgical patients recieving anaesthesia from age ≥18

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patient reported ourcomes

    Behavioral

    Full screening for the perioperative periode

Treatment groups

15,000 Participants
are divided into 1 treatment group
Group A: All patients form age 18 and above1 intervention

Trial outcomes

Primary outcomes

1

Postoperative delirium

Incidence of postoperative Delirium (Nu-DESC score 0-10) 0 is no delirium and 10 is highest delirium

Time frame
Perioperative

Secondary outcomes

1

Patient reported outcome PRO´s

Incidence of PONV (NRS 0-10) 10 is highest nausea 0 is no nausea / yes/no vomiting Incidence of Pain (NRS 0-10) 10 is highest pain 0 is no pain Incidence of Stress (NRS 0-10) 10 is highest stress 0 is no stress Incidence of Anxiety (NRS 0-10)) 10 is highest anxiety 0 is no anxiety Incidence of Sore throat (NRS 0-10) 10 is most sore 0 is no sore Incidents of Wellbeeing (NRS (0-10) 10 is best wellbeeing 0 is no wellbeeing Incidents of Shivering (NRS 0-10) 10 is highest shiviering 0 is no shivering Incidents of Thirst (NRS 0-10) 10 is highest thirst 0 is no thirst

Time frame
Perioperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Nykøbing Falster County Hospital

Collaborator

Ankara University

Collaborator

Naestved Hospital

Collaborator

University of Bern

Collaborator