Anesthesia ComplicationNCT05590845
Evaluating Patient Knowledge About Perioperative Neurocognitive Disorders (KNOW-PND Study)
An observational study of Anesthesia Complication, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
Neurocognitive disorders remain one of the major perioperative complications. They are associated with delayed recovery, prolonged length of hospital stay and impacts on patients' quality of life. The incidence of PND ranges from 15-50%. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia Complication
- What is being tested?
- Survey
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2023to 15 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients scheduled for elective total hip replacement surgery.
Who may be able to join
- age 65 and above
- ASA score 1 to 3
- scheduled for elective hip surgery.
Who cannot join
- insufficient knowledge of Dutch
- known neuropsychiatric conditions
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint-Jan Brugge Oostende AV
Bruges
Sarah Saxena, MD; PHD
About this study
Neurocognitive disorders remain one of the major perioperative complications. They are associated with delayed recovery, prolonged length of hospital stay and impacts on patients' quality of life. The incidence of PND ranges from 15-50%.
While several causes have been investigated, PND seems to be due to the non-resolution of an inflammatory cascade, making some patients more at risk than others. As such, major risk factors include old age and lower education levels.
Read more
As the global proportion of people aged 60 and above between 2015 and 2050 will increase from 12% to 22% and worldwide surgeries increases to >300 million procedures per annum the incidence of perioperative neurocognitive disorders with high morbidity and mortality will go up.
In 2015, the American Society of Anesthesiologists (ASA) launched the 'Perioperative Brain Health Initiative' to increase awareness about perioperative neurocognitive disorders. (PND) While physicians seems to be more and more aware about this condition, data regarding patient awareness are not available.
An observational, single-centre, cross-sectional survey study (with initially a feasibility study) will be conducted in patients, 65 years and above undergoing elective total hip replacement surgery at AZ Sint-Jan (Brugge, Belgium) to assess patients' basic knowledge regarding PND.
- Conditions
- Anesthesia Complication
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patients, 65 and above, scheduled for elective total hip replacement surgery, will be invited to participate in a survey (consisting of 15 questions) testing their knowledge regarding PND.
After completion of the survey, patients will receive a standard preoperative brochure on anaesthesia-related topics and delirium.
T-MOCA scores will be collected (22 = perfect score; <18 = cutoff for cognitive impairment) (through a pre-operative telephone call).
Six weeks post-operatively patients will once again be called for T-moca scores.
Initially a feasibility study for 1/3 of sample size will be done.
What is being measured
The primary outcome is the main question the study is designed to answer.
PND knowledge
Patient knowledge regarding PND will be evaluated through 15 yes/no questions
Measured: 1 week pre-operatively
Secondary outcomes (2)
Baseline cognition
Baseline T-moca scores will be documented in order to evaluate PND presence.
Measured: 1 week pre-operatively
PND
T-moca scores will be documented post-operatively (and compared to baseline scores) in order to evaluate PND presence.
Measured: 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start15 Jan 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Saxena, Université Libre de Bruxelles
- Investigators
- Sarah Saxena, MD;PHD, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590845
- Sponsor's protocol ID
- Know-PND
- Status last verified
- May 2024
- First submitted
- 18 Oct 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request, anonymous data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Knowledge About Perioperative Neurocognitive Disorders (KNOW-PND Study)
- ClinicalTrials.gov ID
- NCT05590845
- Acronym / sponsor ID
- Know-PND
- Conditions
- Anesthesia Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
Neurocognitive disorders remain one of the major perioperative complications. They are associated with delayed recovery, prolonged length of hospital stay and impacts on patients' quality of life. The incidence of PND ranges from 15-50%.
While several causes have been investigated, PND seems to be due to the non-resolution of an inflammatory cascade, making some patients more at risk than others. As such, major risk factors include old age and lower education levels.
As the global proportion of people aged 60 and above between 2015 and 2050 will increase from 12% to 22% and worldwide surgeries increases to >300 million procedures per annum the incidence of perioperative neurocognitive disorders with high morbidity and mortality will go up.
In 2015, the American Society of Anesthesiologists (ASA) launched the 'Perioperative Brain Health Initiative' to increase awareness about perioperative neurocognitive disorders. (PND) While physicians seems to be more and more aware about this condition, data regarding patient awareness are not available.
An observational, single-centre, cross-sectional survey study (with initially a feasibility study) will be conducted in patients, 65 years and above undergoing elective total hip replacement surgery at AZ Sint-Jan (Brugge, Belgium) to assess patients' basic knowledge regarding PND.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients scheduled for elective total hip replacement surgery.
Key inclusion criteria (3 listed)
- age 65 and above
- ASA score 1 to 3
- scheduled for elective hip surgery.
Key exclusion criteria (2 listed)
- insufficient knowledge of Dutch
- known neuropsychiatric conditions
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 |
|---|---|---|
| SurveyPatients, 65 and above, scheduled for elective total hip replacement surgery, will be invited to participate in a survey (consisting of 15 questions) testing their knowledge regarding PND. After completion of the survey, patients will receive a standard preoperative brochure on anaesthesia-related topics and delirium. T-MOCA scores will be collected (22 = perfect score; <18 = cutoff for cognitive impairment) (through a pre-operative telephone call). Six weeks post-operatively patients will once again be called for T-moca scores. Initially a feasibility study for 1/3 of sample size will be done. | Other | – |
Primary outcome
PND knowledge
Time frame: 1 week pre-operatively
Patient knowledge regarding PND will be evaluated through 15 yes/no questions
2 secondary outcomes
Baseline cognition
Time frame: 1 week pre-operatively
PND
Time frame: 6 weeks post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided. Upon reasonable request, anonymous data will be shared.
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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.
Sarah Saxena, MD;PHD principal investigator
AZ Sint-Lucas Brugge
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 Anesthesia Complication, run by Université Libre de Bruxelles at 1 site in Belgium.
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 3 inclusion and 2 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 6 Dec 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 Belgium. 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 Sarah Saxena, MD; PHD (+3250452111, sarah.saxena@ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PND knowledge (time frame: 1 week pre-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2024.