NCT04598178

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2021

Completed
Last Updated

May 6, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

October 18, 2020

Last Update Submit

May 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normative taiwan people

You may qualify if:

  • adults no less than 20years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH, Taipei, Taiwan

Taipei, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 19225398BACKGROUND
  • 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.

    PMID: 30348620BACKGROUND
  • 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. doi: 10.1097/01.anes.0000296071.19434.1e.

    PMID: 18156878BACKGROUND
  • 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.

    PMID: 30507928BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Fon-Yih Tsuang, Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 22, 2020

Study Start

August 4, 2020

Primary Completion

February 27, 2021

Study Completion

February 27, 2021

Last Updated

May 6, 2021

Record last verified: 2021-04

Locations