NCT05406843

Brief Summary

To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late postoperative periods by comparing the preop and postop period mini mental status tests in participants undergoing open heart surgery, and to compare the results of the investgators clinic with the world literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

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

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

February 18, 2021

Last Update Submit

June 8, 2022

Conditions

Keywords

COGNITIVE DYSFUNCTİONHEART SURGERYPOSTOPERATIVE DELIRIUM

Outcome Measures

Primary Outcomes (1)

  • Evaluation of postoperative cognitive functions in participants undergoing open heart surgery.

    The aim is to understand whether there is a loss of cognitive functions in the postoperative period, according to the preoperative periods, by testing the participants with open heart surgery on the 3rd day, 7th day, and 2nd month after the surgery.

    1 year

Secondary Outcomes (1)

  • Comparison with the literature.

    1 year

Study Arms (2)

Preoperative cognitive status of participants undergoing open heart surgery

Detection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period. In this study, it was aimed to determine postoperative cognitive impairment by comparing cognitive functions by using Minimental status test in the preoperative period in participants scheduled for open heart surgery for one year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time.

Other: Preoperative cognitive functions of participants undergoing open heart surgery

Postoperative cognitive status of participants undergoing open heart surgery

Detection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period. In this study, it was aimed to determine the postoperative cognitive impairment by comparing it with the cognitive functions in the preoperative period using the Minimental status test in the postoperative period in participants scheduled for open heart surgery for a year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time.

Other: Postoperative cognitive functions of particiants undergoing open heart surgery

Interventions

Surgery times and cross-clamping times of the participants who will undergo open heart surgery were recorded.

Preoperative cognitive status of participants undergoing open heart surgery

Changes in mini mental test scores were recorded in the postoperative period.

Postoperative cognitive status of participants undergoing open heart surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A study was planned on 140 patients undergoing open heart surgery.

You may qualify if:

  • age
  • American Society of Anesthesiologists (ASA) II-III

You may not qualify if:

  • \>75 age
  • \<18 age
  • Patients who died within 48 hours after the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

Kocaeli, İzmit, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Cognitive ComplicationsCognition DisordersEmergence Delirium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionNeurocognitive DisordersMental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Tülay Çardaközü

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant

Study Record Dates

First Submitted

February 18, 2021

First Posted

June 7, 2022

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

August 1, 2021

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

all collected individual participant data

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
starting 6 months after publication
Access Criteria
The study results can be accessed by anyone who is a healthcare worker.

Locations