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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05590845
Other study ID # Know-PND
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2023
Est. completion date December 15, 2024

Study information

Verified date May 2024
Source Université Libre de Bruxelles
Contact Sarah Saxena, MD; PHD
Phone +3250452111
Email sarah.saxena@ulb.ac.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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%. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
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.

Locations

Country Name City State
Belgium AZ Sint-Jan Brugge Oostende AV Brugge

Sponsors (1)

Lead Sponsor Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary PND knowledge Patient knowledge regarding PND will be evaluated through 15 yes/no questions 1 week pre-operatively
Secondary Baseline cognition Baseline T-moca scores will be documented in order to evaluate PND presence. 1 week pre-operatively
Secondary PND T-moca scores will be documented post-operatively (and compared to baseline scores) in order to evaluate PND presence. 6 weeks post-operatively
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