- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228546
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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 Locations
-
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Yüreğir
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Adana, Yüreğir, Turkey (Türkiye), 01370
- Tuna Şahin
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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
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
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
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)
May 12, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
September 30, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Estimated)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 4, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID 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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