Postoperative Cognitive DysfunctionNCT04598178
Normative Data for the Qmci-TW in a Taiwanese Sample
An observational study of Postoperative Cognitive Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Many perioperative factors have been pointed out as the risk factors for postoperative cognitive dysfunction, which may occur immediately after the surgery, days after the surgery, or months after the surgery. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2020to 27 Feb 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normative taiwan people
Who may be able to join
- adults no less than 20years old
Who cannot join
- pregnant women
- patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%]
- patients with heart failure(NYHA score =III、IV)
- patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2)
- patients with liver failure
- patients with ongoing infection
- patients have surgery or hospital admission in the past half year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normative Data for the Quick Mild Cognitive Impairment-Taiwan Version (Qmci- TQ) in a Taiwanese Sample
Many perioperative factors have been pointed out as the risk factors for postoperative cognitive dysfunction, which may occur immediately after the surgery, days after the surgery, or months after the surgery. Quick mild cognitive impairment screen (Qmci) is a sensitive and specific test to differentiate mild postoperative cognitive dysfunction. However, the learning effect have been raised as a bias when we repeated the same test for one person at different timing. Thus the study is designed to collected the Normative Data in series for the Qmci-TW in a Taiwanese Sample.
- Conditions
- Postoperative Cognitive Dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
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 |
|---|---|---|
| Taiwan Cohort | For normative Taiwan people, cognitive function will be assessed by the Taiwan version of questionnaire Qmci (Qmci-TW) on Day 0, Day 2, Day 180. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function by the Taiwan version of questionnaire Qmci (Qmci-TW)
Qmci is a screening assessment developed to detect mild cognitive impairment. It's a 100-point test administered in approximately 10 minutes. A score of 60 or over is considered to be normal. The validity of the Taiwan version of Qmci has been established.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start4 Aug 2020
- Primary completion27 Feb 2021
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fon-Yih Tsuang, Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598178
- Sponsor's protocol ID
- 202002051RINA
- Status last verified
- Apr 2021
- First submitted
- 18 Oct 2020
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
PubMed 19225398Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19.
PubMed 30348620Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
PubMed 18156878Lee MT, Chang WY, Jang Y. Psychometric and diagnostic properties of the Taiwan version of the Quick Mild Cognitive Impairment screen. PLoS One. 2018 Dec 3;13(12):e0207851. doi: 10.1371/journal.pone.0207851. eCollection 2018.
PubMed 30507928
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data for the Quick Mild Cognitive Impairment-Taiwan Version (Qmci- TQ) in a Taiwanese Sample
- ClinicalTrials.gov ID
- NCT04598178
- Acronym / sponsor ID
- 202002051RINA
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 22 Oct 2020 (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.
Many perioperative factors have been pointed out as the risk factors for postoperative cognitive dysfunction, which may occur immediately after the surgery, days after the surgery, or months after the surgery. Quick mild cognitive impairment screen (Qmci) is a sensitive and specific test to differentiate mild postoperative cognitive dysfunction. However, the learning effect have been raised as a bias when we repeated the same test for one person at different timing. Thus the study is designed to collected the Normative Data in series for the Qmci-TW in a Taiwanese Sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taiwan Cohort | – | –For normative Taiwan people, cognitive function will be assessed by the Taiwan version of questionnaire Qmci (Qmci-TW) on Day 0, Day 2, Day 180. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normative taiwan people
Key inclusion criteria (1 listed)
- adults no less than 20years old
Key exclusion criteria (7 listed)
- pregnant women
- patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%]
- patients with heart failure(NYHA score =III、IV)
- patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2)
- patients with liver failure
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
cognitive function by the Taiwan version of questionnaire Qmci (Qmci-TW)
Time frame: 180 days
Qmci is a screening assessment developed to detect mild cognitive impairment. It's a 100-point test administered in approximately 10 minutes. A score of 60 or over is considered to be normal. The validity of the Taiwan version of Qmci has been established.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 19225398Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
- Background: PubMed 30348620Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19.
- Background: PubMed 18156878Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
- Background: PubMed 30507928Lee MT, Chang WY, Jang Y. Psychometric and diagnostic properties of the Taiwan version of the Quick Mild Cognitive Impairment screen. PLoS One. 2018 Dec 3;13(12):e0207851. doi: 10.1371/journal.pone.0207851. eCollection 2018.
Related trials for Postoperative Cognitive Dysfunction
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
Not yet recruitingObservational study
Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Neurocognitive Disorder, Cardiac Surgery
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.
Fon-Yih Tsuang, Ph.D. principal investigator
National Taiwan University Hospital
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 Postoperative Cognitive Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 6 May 2021. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function by the Taiwan version of questionnaire Qmci (Qmci-TW) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598178, which also lists 4 linked publications.
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 May 2021.