The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes

NCT06028568 | Unknown

• 1 other identifier: KY20232188-C-1
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to analyze the reliability and validity of the results of the new designed perioperative cognitive test network platform, and to judge the reliability and scientific nature of the perioperative cognitive test. And then to explore whether the perioperative cognitive test network platform can be used to evaluate the changes of perioperative cognitive function of patients.

Conditions

Perioperative Neurocognitive Disorders

Outcome Measures

Primary Outcomes (2)

• Reliability

  Cronbach's alpha is used to assess the reliability and the internal consistency of this Cognitive test. Cronbach's alpha value \>0.7 indicating the reliability of the test is acceptable.

  Baseline Test：1 day before operation, Second Test: Day 7 after operation

• Validity

  Content validity, Construct validity and Responsiveness analysis are used to evaluate the validity of the cognitive test. The item-content validity index (I-cvi) is used evaluate the Content validity. I-cvi≥ 0.78 means the content validity is satisfactory. The Exploratory Factor Analysis (EFA) is used evaluate the Construct validity. The Kaiser-Mayer-Olkin (KMO) index (\>0.6) is used to evaluate adaptability for factor analysis. Factor loading should \>0.4. The Responsiveness analysis is used to evaluate the ability of this cognitive test that can reflect the change of cognitive function of the Interviewer during operation. Paired t-test can be used to compare whether the difference in score before and after is statistically significant. P value should \< 0.05.

  Baseline Test：1 day before operation, Second Test: Day 7 after operation

Secondary Outcomes (1)

• PND (Perioperative neurocognitive disorders)

  Baseline Test：1 day before operation, Second Test: Day 7 after operation

Study Arms (2)

Elderly patients undergoing surgery

Older than or equal to 65 years of age; patients who intend to undergo major abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)

Elderly healthy volunteers

Age-and sex-matched community population

Eligibility Criteria

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

Study Population

This study will include two groups: elderly healthy volunteers and elderly patients undergoing abdominal surgery.

You may qualify if:

• Age over 65
• Scheduled for abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)
• Informed consent has been obtained
• Healthy volunteer groups are listed as age-and sex-matched community groups

You may not qualify if:

• Unable to follow instruction and finish the firtst procedure
• Has severe visual or auditory problems
• History of drug or alcohol abuse (drinking more than 5U daily in the past 3 months, 1U equals 10ml or 8g pure alcohol, equivalent to \>50 liquor over 100ml, two two
• Are diagnosed neuropsychological disease that needs treatment
• Clear history of severe cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), Parkinson's syndrome, schizophrenia, bipolar disorder, depression, dementia, Alzheimer's disease, etc
• Severe head trauma, carbon monoxide poisoning and other loss of consciousness more than 30 minutes
• MMSE score ≤23
• Participated this study or being participating other clinical research

Sponsors & Collaborators

• Xijing Hospital: lead

Central Study Contacts

Zhixin Wu, physician

CONTACT

18392187971; wuzhixin212@163.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-06