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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598178
Other study ID # 202002051RINA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 4, 2020
Est. completion date February 27, 2021

Study information

Verified date April 2021
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 27, 2021
Est. primary completion date February 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - adults no less than 20years old Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan NTUH, Taipei, Taiwan Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Alam 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. Review. — View Citation

Lee 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. — View Citation

Monk 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 180 days
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