- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05590845
Evaluating Patient Knowledge About Perioperative Neurocognitive Disorders (KNOW-PND 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.
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 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 Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sarah Saxena, MD; PHD
- Phone Number: +3250452111
- Email: sarah.saxena@ulb.ac.be
Study Locations
-
-
-
Brugge, Belgium
- Recruiting
- AZ Sint-Jan Brugge Oostende AV
-
Contact:
- Sarah Saxena, MD; PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 65 and above
- ASA score 1 to 3
- scheduled for elective hip surgery.
Exclusion Criteria:
- insufficient knowledge of Dutch
- known neuropsychiatric conditions
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PND knowledge
Time Frame: 1 week pre-operatively
|
Patient knowledge regarding PND will be evaluated through 15 yes/no questions
|
1 week pre-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline cognition
Time Frame: 1 week pre-operatively
|
Baseline T-moca scores will be documented in order to evaluate PND presence.
|
1 week pre-operatively
|
PND
Time Frame: 6 weeks post-operatively
|
T-moca scores will be documented post-operatively (and compared to baseline scores) in order to evaluate PND presence.
|
6 weeks post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Saxena, MD;PHD, AZ Sint-Jan Brugge-Oostende AV
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Know-PND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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