Perioperative Neurocognitive DisordersNCT06028568
The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes
An observational study of Perioperative Neurocognitive Disorders, run by Xijing Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioperative Neurocognitive Disorders
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Mar 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
- Healthy volunteers accepted
- Older adult
Study population: This study will include two groups: elderly healthy volunteers and elderly patients undergoing abdominal surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Perioperative Neurocognitive Function Changes in Patients Undergoing Surgery
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.
Read the detailed description
Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery will be included in this study. The cognitive function of the patients was tested one day before and seven days after operation. Healthy volunteers had two cognitive function tests at the same interval. The normality test is used to evaluate whether the test results accord with the normal distribution. The internal consistency of the test was evaluated by calculating the Cronbach coefficient, the content validity was evaluated by experts and the content validity index was calculated, and the construct validity of the test was evaluated by exploratory factor analysis and confirmatory factor analysis. The validity of the test was evaluated by calculating the effect scale.
- Conditions
- Perioperative Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline Test：1 day before operation, Second Test: Day 7 after operation
Secondary outcomes (1)
PND (Perioperative neurocognitive disorders)
PND is diagnosed by calculating the Z-score. The investigators get the score or accuracy and completion time of each test through the cognitive test network platform.
Then Calculate Z-score: For each test, the mean practice effect is subtracted from the difference between preoperative and postoperative test scores; the result is then divided by the control group standard deviation to obtain a z-score. The z-scores of all tests in an individual patient are summarized and divided by the standard deviations for this sum of z-scores in the control subjects, creating a composite z-score.
Cognitive decline is defined when two z-scores in individual tests or the composite z-score ≤-1.96.
Perioperative neurocognitive disorders (PND) mainly refer to neurocognitive decline detected after surgery and anesthesia.
Measured: Baseline Test：1 day before operation, Second Test: Day 7 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028568
- Sponsor's protocol ID
- KY20232188-C-1
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Perioperative Neurocognitive Function Changes in Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06028568
- Acronym / sponsor ID
- KY20232188-C-1
- Conditions
- Perioperative Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 8 Sep 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.
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.
Detailed description
Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery will be included in this study. The cognitive function of the patients was tested one day before and seven days after operation. Healthy volunteers had two cognitive function tests at the same interval. The normality test is used to evaluate whether the test results accord with the normal distribution. The internal consistency of the test was evaluated by calculating the Cronbach coefficient, the content validity was evaluated by experts and the content validity index was calculated, and the construct validity of the test was evaluated by exploratory factor analysis and confirmatory factor analysis. The validity of the test was evaluated by calculating the effect scale.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will include two groups: elderly healthy volunteers and elderly patients undergoing abdominal surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability
Time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
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.
Validity
Time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
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.
1 secondary outcome
PND (Perioperative neurocognitive disorders)
Time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Neurocognitive Disorders, run by Xijing Hospital.
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 4 inclusion and 8 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Zhixin Wu, physician (18392187971, wuzhixin212@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation). The study lists 2 primary outcomes in all. 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 14 Sep 2023.