Neurocognitive DisordersSBINCT05765162
Safe Brain Initiative, Operationalizing Precision Anaesthesia
An observational study of Neurocognitive Disorders and Post Operative Delirium, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders, Post Operative Delirium, Pain
- What is being tested?
- Patient reported ourcomes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2021to 1 Jan 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: • All surgical patients recieving anaesthesia from age ≥18
Who may be able to join
- All patients from age ≥18
Who cannot join
- All patients from age <18
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Nykøbing Falster Hospital
Nykøbing Falster, 4800
Finn M. Radtke, Professor, +4915127067901, finnmradtke@me.com
About this study
Official 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.
Read more
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.
Read the 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
- Being tested
- Patient reported ourcomes
- Medical subject headings
- Neurocognitive Disorders, Emergence Delirium, Pain, Nausea, Vomiting, Anxiety Disorders, Psychomotor Agitation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient reported ourcomesBehavioural
Full screening for the perioperative periode
| Study group | Role | What they receive |
|---|---|---|
| All patients form age 18 and above | All patients form age 18 and above Receives: Behavioral: Patient reported ourcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Incidence of postoperative Delirium (Nu-DESC score 0-10) 0 is no delirium and 10 is highest delirium
Measured: Perioperative
Secondary outcomes (1)
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
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Dec 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Nykøbing Falster County Hospital, Ankara University, Naestved Hospital, University of Bern
- Responsible party
- Principal investigator, Finn M. Radtke, University of Southern Denmark
- Investigators
- Finn M. Radtke, Professor, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765162
- Sponsor's protocol ID
- REG-117-2019
- Acronym
- SBI
- Status last verified
- Jun 2024
- First submitted
- 7 Nov 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized patient outcome data (PRO´s)
Publications
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.
PubMed 38972091
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Brain Initiative - Dedicated to Advancing Anaesthesia and Perioperative Personalised Care Towards Precision Anaesthesia Care. A Continuous Quality Improvement Initiative.
- ClinicalTrials.gov ID
- NCT05765162
- Acronym / sponsor ID
- SBI / REG-117-2019
- Conditions
- Neurocognitive Disorders, Post Operative Delirium, Pain, Nausea, Vomiting, Wellbeing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Nykøbing Falster County Hospital, Ankara University, Naestved Hospital, University of Bern
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients form age 18 and above | – | Behavioral: Patient reported ourcomesAll patients form age 18 and above |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- • All surgical patients recieving anaesthesia from age ≥18
Key inclusion criteria (1 listed)
- All patients from age ≥18
Key exclusion criteria (1 listed)
- All patients from age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient reported ourcomesFull screening for the perioperative periode | Behavioural | All patients form age 18 and above |
Primary outcome
Postoperative delirium
Time frame: Perioperative
Incidence of postoperative Delirium (Nu-DESC score 0-10) 0 is no delirium and 10 is highest delirium
1 secondary outcome
Patient reported outcome PRO´s
Time frame: Perioperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 38972091Meco 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.
- Individual participant dataSharing planned: Undecided. Anonymized patient outcome data (PRO´s)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn M. Radtke, Professor principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders and Post Operative Delirium, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Finn M. Radtke, Professor (+4915127067901, finnmradtke@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05765162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.