Safe Brain Initiative, Operationalizing Precision Anaesthesia

Pain Clinical Trial

— SBI  

Official title:

Safe Brain Initiative - Dedicated to Advancing Anaesthesia and Perioperative Personalised Care Towards Precision Anaesthesia Care. A Continuous Quality Improvement Initiative.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765162
• Other study ID #: REG-117-2019
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2024
• Source: University of Southern Denmark
• Contact: Finn M. Radtke, Professor
• Phone: +4915127067901
• Email: finnmradtke[@]me.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

The SBI core recommendations aim to monitor, detect and ultimately decrease and avoid the adverse side effects of surgery and anaesthesia in our daily routine care.Thereby guiding clinicians on the least invasive and least side effect-prone pathway through the perioperative process.Currently, the Safe Brain Initiative has 18 core recommendations available. All recommendations are non-invasive by nature, with the primary goal of detecting and preventing/reducing adverse outcomes.

SBI-Muda identifies both direct and derived economic effects. Despite being a central component of the broader SBI project, it also deserves and requires a specific focus. An inefficient OR management results in patient frustration, delays for the healthcare professionals, and a reduction in teamwork. Long waiting times can also increase stress and anxiety, prolong fluid fasting times, and exacerbate postoperative complications.

SBI-Muda will improve OR efficiency, reduce POD/PND, and improve patient-reported outcomes (PRO). By providing detailed SBI-Muda dashboard updates and feedback on OR and hospital metrics and placing them in context with the individual's outcomes (e.g., starting time or delay, suture to incision time, time spent in the postanaesthesia care unit (PACU) and postoperative time spent in the hospital). With SBI-Muda, the department as a whole and the healthcare specialist will have access to anonymized- more objective- systematized feedback on the quality of care and the metrics related to the perioperative process.

The SBI-Us functionality focuses on assessing the subjective quality of care provided by professional service providers (nurses, doctors, and other staff) and aligning this with patient-reported quality of care. In this regard, staff members will receive a brief anonymous questionnaire regarding their perception of treatment quality over the last three months. The results will be available to single health care professionals through SBI-me and the department as a whole.

SBI-Us provides a bidirectional perspective, including the patients' and the health care providers' perspectives, for benchmarking improvements in both areas and providing holistic, balanced information on the quality of care in the perioperative setting.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Anxiety
• Body Temperature Changes
• Emergence Delirium
• Fasting
• Nausea
• Neurocognitive Disorders
• Pain
• Pharyngitis
• Post Operative Delirium
• Psychomotor Agitation
• Satisfaction, Patient
• Sedation Complication
• Shivering
• Stress
• Temperature Change, Body
• Thirst
• Vomiting
• Wellbeing

Intervention

Behavioral:
• Patient reported ourcomes
Full screening for the perioperative periode

Locations

Country	Name	City	State
Denmark	Nykøbing Falster Hospital	Nykøbing Falster

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Ankara University, Naestved Hospital, Nykøbing Falster County Hospital, University of Bern

Country where clinical trial is conducted

Denmark, 

Outcome

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