Safe Brain Initiative, Operationalizing Precision Anaesthesia

NCT ID: NCT05765162

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2026-01-01

Brief 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.

Detailed 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.

Conditions

Neurocognitive Disorders; Post Operative Delirium; Pain; Nausea; Vomiting; Wellbeing; Shivering; Anxiety; Stress; Agitation,Psychomotor; Sedation Complication; Thirst; Satisfaction, Patient; Temperature Change, Body; Fasting; Sore-throat; Hearing and Vision Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients form age 18 and above

All patients form age 18 and above

Patient reported ourcomes

Intervention Type: BEHAVIORAL

Full screening for the perioperative periode

Interventions

Patient reported ourcomes

Full screening for the perioperative periode

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All patients from age ≥18

Exclusion Criteria

• All patients from age <18

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nykøbing Falster County Hospital

OTHER

Sponsor Role: collaborator

Ankara University

OTHER

Sponsor Role: collaborator

Naestved Hospital

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Finn M. Radtke

Finn M. Radtke Ass. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Finn M. Radtke, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

Nykøbing Falster Hospital

Nykøbing Falster, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Finn M. Radtke, Professor

Role: CONTACT

finnmradtke@me.com

+4915127067901

Karina Jakobsen, MCN

Role: CONTACT

kjak@regionsjaelland.dk

+4530954795

Facility Contacts

Finn M. Radtke, Professor

Role: primary

finnmradtke@me.com

+4915127067901

References

Meco BC, Jakobsen K, De Robertis E, Buhre W, Alkis N, Kirkegaard PR, Hagi-Pedersen D, Bubser F, Koch S, Evered LA, Saunders SJ, Caterino M, Paolini F, Berger-Estilita J, Radtke FM. A first assessment of the safe brain initiative care bundle for addressing postoperative delirium in the postanesthesia care unit. J Clin Anesth. 2024 Oct;97:111506. doi: 10.1016/j.jclinane.2024.111506. Epub 2024 Jul 6.

Reference Type: DERIVED

PMID: 38972091 (View on PubMed)

Other Identifiers

REG-117-2019

Identifier Type: -

Identifier Source: org_study_id