NCT05798767

Brief Summary

Preoperative cognitive impairment (PCI) may increase the incidence of postoperative delirium (POD), yet screening for cognitive impairment is rarely performed. This study hypothesized that Mini-Cog for preoperative cognitive impairment screening predicts postoperative delirium. Elderly patients (65 years or older) attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery were recruited into the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

March 22, 2023

Last Update Submit

March 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • delirium

    postoperative delirium accessed by the Short Confusion Assessment Method (CAM)

    February 2022 to March 2023

Study Arms (2)

PCI group

Patients with a Mini-Cog score of 3 or less were in the PCI group

Behavioral: Neuropsychological tests

Normal group

Patients with a Mini-Cog score of 3 or 4 were in the normal group

Behavioral: Neuropsychological tests

Interventions

Cognitive function screening (Mini-Cog; the Mini-mental State Examination, MMSE), depression screening (Patient Health Questionnaire-9, PHQ-9), sleep quality assessment (Pittsburgh Sleep Quality Index, PSQI), and pain assessment (Numeric Rating Scale, NRS) were performed the day before surgery. The Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium.

Normal groupPCI group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery

You may qualify if:

  • years of age or older,
  • elective thoracic surgery,
  • under general anesthesia.

You may not qualify if:

  • history of psychiatric disorders,
  • use of any antipsychotic drugs,
  • ASA score \>3
  • severe visual, hearing, or physical dysfunction unable to complete the scale
  • advanced malignant tumors of the chest with distant metastases to bone, liver, etc.,
  • history of general anesthesia surgery in the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan People's Hospital

Zhengzhou, China

Location

Related Publications (1)

  • Li F, Miao M, Li N, Zhou J, Sun M, Zhang J. Prevalence of preoperative cognitive impairment among elderly thoracic surgery patients and association with postoperative delirium: a prospective observational study. Front Hum Neurosci. 2023 Jul 20;17:1234018. doi: 10.3389/fnhum.2023.1234018. eCollection 2023.

MeSH Terms

Conditions

Neurocognitive DisordersCognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Mental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

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

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 5, 2023

Study Start

February 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

April 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations