Pain Clinical Trial
— SBIOfficial title:
Safe Brain Initiative - Dedicated to Advancing Anaesthesia and Perioperative Personalised Care Towards Precision Anaesthesia Care. A Continuous Quality Improvement Initiative.
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.
Status | Recruiting |
Enrollment | 15000 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: • All patients from age =18 Exclusion Criteria: • All patients from age <18 |
Country | Name | City | State |
---|---|---|---|
Denmark | Nykøbing Falster Hospital | Nykøbing Falster |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Ankara University, Naestved Hospital, Nykøbing Falster County Hospital, University of Bern |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative delirium | Incidence of postoperative Delirium (Nu-DESC score 0-10) 0 is no delirium and 10 is highest delirium | Perioperative | |
Secondary | 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 | Perioperative |
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