NCT04312516

Brief Summary

Postoperative neurocognitive disorders, including postoperative delirium (POD) and postoperaive cognitive dysfunction (POCD), are common complications of perioperative neurocognition in elderly patients undergoing surgery. POD and POCD have short- and long-term consequences, such as increased hospital stays and costs, augmented morbidity and mortality, as well as higher risk for cognitive decline later in life. Therefore, early prevention and diagnosis of these conditions is of great importance. A number of psychometric tests have been proposed as cognitive screening tools. Given the fact that many of them show weaknesses and difficulties in performance, scientists have sought for more useful alternatives. Montreal Cognitive Assessment (MoCA) is considered to be a good choice, as it has been successfully applied in the perioperative setting. What's more, it has been translated and validated for a Greek population with neurological disorders. Addenbrooke's Congnitive Examination III (ACE III) has been introduced recently into clinical practice. It is an easy to perform and detailed test that covers several neurocognitive domains and has shown high sensitivity and specificity in clinical conditions, including dementia and Alzheimer's disease. Although current literature lacks data concerning its perioperative use, ACE III could prove useful for screening patients undergoing surgery and anesthesia on the basis of its favorable characteristics as mentioned above. The aim of this study is to translate the ACE III (English version 2012) into Greek and assess its validity in perioperative patients aged \>55 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

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

First Submitted

Initial submission to the registry

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2022

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

March 16, 2020

Last Update Submit

May 31, 2024

Conditions

Keywords

ACE IIIMoCANeurocognitive dysfunctionPerioperative

Outcome Measures

Primary Outcomes (2)

  • Cultural adaption

    Cultural adaption of ACE III (English version 2012) into the Greek language

    2 months

  • Validation

    Construct and convergent validity of the translated version of ACE III into the Greek language

    2 months

Study Arms (2)

Controls

Participants scheduled for surgery with MoCA score ≥ 26 preoperatively

Patients

Participants scheduled for surgery with MoCA score \< 26 preoperatively

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

128 surgical patients (cognitively and non-cognitively impaired)

You may qualify if:

  • Patients scheduled for surgical intervention
  • At least of primary level of education

You may not qualify if:

  • Neurodegenerative disease
  • Cerebrovascular disease
  • Psychiatric disorders
  • History of head injury
  • Use of medication affecting the CNS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Emergence DeliriumPostoperative Cognitive ComplicationsCognition Disorders

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersCognitive Dysfunction

Study Officials

  • Maria Zouka, MD

    AHEPA University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant - Principal Investigator

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

October 15, 2021

Primary Completion

November 30, 2021

Study Completion

December 18, 2022

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations