The Effects of Demographic and Clinical Data of Patients on Cerebral Oxygen Monitoring Values

January 4, 2026 updated by: Tuna Şahin

The Effects of Demographic and Clinical Data of Patients on the Assessment of Cerebral Oxygen Monitoring Values Applied During Coronary Artery Bypass Grafting

The aim of this study is to examine the effects of patients' clinical and demographic datas on cerebral oxygen saturation values. Brain oxygenation is measured using near infrared spectroscopy (NIRS). The primary outcome measure of the study is the regional oxygen saturation (rSO2) values measured on the monitor at twelve time points. The other primary outcome measures consist of baseline arterial and venous blood gas analysis and baseline activated clotting time measurements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This prospective observational study analyzes 80 patients between the ages of 25-80 years who are undergoing elective coronary artery bypass grafting (CABG) surgery. Demographic data of the patients such as age, gender, comorbidities, body mass index are recorded. In addition to standard monitoring, cerebral oximetry monitoring (NIRS) is applied to the patients. Baseline arterial and venous blood gas analysis values, baseline activated clotting time measurements are recorded. Durations of anesthesia, surgery , cardiopulmonary bypass , aortic cross- clamping are recorded. Time points for rSO2 values are baseline, induction, sternotomy, cannulation, pump entry, cross clamp placement, 34º C ,36º C, lowest temperature, cross clamp removal, pump exit, skin closure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing elective coronary artery bypass grafting surgery

Description

Inclusion criteria:

  • Accepting to participate in the study
  • Undergoing elective coronary artery bypass grafting surgery
  • Age 25-80 years Ejection fraction 30% and above

Exclusion criteria:

  • Non volunteers
  • Age <25 or >80 years
  • Ejection fraction below 30%
  • Patients with history of neurological disease or neurosurgery
  • Emergency surgery
  • Concurrent valve surgery
  • Patients with history of carotid artery stenosis
  • Patients with need for preoperative intraaortic balloon pump or inotropic support

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Regional oxygen saturation values
Time Frame: Baseline and peroperative measurements until the and of surgery
Regional oxygen saturation values measurement at twelve points.
Baseline and peroperative measurements until the and of surgery
Baseline arterial blood gas analysis
Time Frame: Within 5 minutes after arterial cannulation for the baseline measurement
The baseline arterial blood gas sample taken from the patient after arterial cannulation
Within 5 minutes after arterial cannulation for the baseline measurement
Venous blood gas analysis
Time Frame: Within 5 minutes after central jugular venous cannulation
Venous blood gas sample taken from the patient after central jugular venous cannulation
Within 5 minutes after central jugular venous cannulation
Baseline activated clotting time measurement
Time Frame: Within 5 minutes after arterial cannulation for the baseline measurement
The baseline measurement of activated clotting time after arterial cannulation
Within 5 minutes after arterial cannulation for the baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tuna Şahin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Adana City TRH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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