Safe Brain Initiative, Operationalizing Precision Anaesthesia

NCT05765162 | Recruiting DMC

• 1 other identifier: REG-117-2019
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium

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

  Perioperative

Secondary Outcomes (1)

• Patient reported outcome PRO´s

  Perioperative

Study Arms (1)

All patients form age 18 and above

All patients form age 18 and above

Behavioral: Patient reported ourcomes

Interventions

Patient reported ourcomes BEHAVIORAL

Full screening for the perioperative periode

All patients form age 18 and above

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

• All surgical patients recieving anaesthesia from age ≥18

You may qualify if:

• All patients from age ≥18

You may not qualify if:

• All patients from age \<18

Sponsors & Collaborators

• University of Southern Denmark: lead
• Nykøbing Falster County Hospital: collaborator
• Ankara University: collaborator
• Naestved Hospital: collaborator
• University of Bern: collaborator

Study Sites (1)

Nykøbing Falster Hospital

Nykøbing Falster, 4800, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 38972091 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders; Emergence Delirium; Pain; Nausea; Vomiting; Anxiety Disorders; Psychomotor Agitation; Patient Satisfaction; Body Temperature Changes; Fasting; Pharyngitis; Deaf-Blind Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Signs and Symptoms, Digestive; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Feeding Behavior; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Deafness; Hearing Loss; Hearing Disorders; Ear Diseases; Sensation Disorders; Blindness; Vision Disorders; Eye Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Finn M. Radtke, Professor

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn M. Radtke, Professor

CONTACT

+4915127067901; finnmradtke@me.com

Karina Jakobsen, MCN

CONTACT

+4530954795; kjak@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Finn M. Radtke Ass. Professor

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: March 13, 2023
• Study Start: December 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

DK (1)