Safe Brain Initiative, Operationalizing Precision Anaesthesia (SBI)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Wellbeing; Neurocognitive Disorders; Nausea; Vomiting; Stress; Anxiety; Satisfaction, Patient; Fasting; Temperature Change, Body; Thirst; Sedation Complication; Shivering; Agitation,Psychomotor; Hearing and Vision Loss; Sore-throat; Post Operative Delirium
• Intervention / Treatment: Behavioral: Patient reported ourcomes

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.

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Finn M. Radtke, Professor; Phone Number: +4915127067901; Email: finnmradtke@me.com
• Study Contact Backup: Name: Karina Jakobsen, MCN; Phone Number: +4530954795; Email: kjak@regionsjaelland.dk

Study Locations

• Denmark
  • Nykøbing Falster, Denmark, 4800
    • Recruiting
    • Nykøbing Falster Hospital
    • Contact: Finn M. Radtke, Professor; Phone Number: +4915127067901; Email: finnmradtke@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• All patients from age ≥18

Description

Inclusion Criteria:

• All patients from age ≥18

Exclusion Criteria:

• All patients from age <18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients form age 18 and above	Behavioral: Patient reported ourcomes; Full screening for the perioperative periode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Incidence of postoperative Delirium (Nu-DESC score 0-10)	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome PRO´s	Incidence of PONV (NRS 0-10) Incidence of high pain (NRS 0-10) Incidence of Stress (NRS 0-10) Incidence of Anxiety (NRS 0-10)) Incidence of sore throat (NRS 0-10)	Perioperative

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: University of Bern; Naestved Hospital; Nykøbing Falster County Hospital; Ankara University
• Investigators: Principal Investigator: Finn M. Radtke, Professor, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Eye Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Signs and Symptoms, Digestive; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Dyskinesias; Psychomotor Disorders; Sensation Disorders; Abnormalities, Multiple; Hearing Disorders; Vision Disorders; Blindness; Hearing Loss; Deafness; Vomiting; Psychomotor Agitation; Body Temperature Changes; Pharyngitis; Neurocognitive Disorders; Deaf-Blind Disorders
• Other Study ID Numbers: REG-117-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymized patient outcome data (PRO´s)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No