Cerebral Oxygen SaturationNCT07228546
The Effects of Demographic and Clinical Data of Patients on Cerebral Oxygen Monitoring Values
An observational study of Cerebral Oxygen Saturation, run by Tuna Şahin at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Cerebral Oxygen Saturation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective coronary artery bypass grafting surgery
Who may be able to join
- Accepting to participate in the study
- Undergoing elective coronary artery bypass grafting surgery
- Age 25-80 years Ejection fraction 30% and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Oxygen Saturation
- Keywords
- near infrared spectroscopy, coronary artery bypass grafting, regional cerebral oxygen saturation
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional oxygen saturation values
Regional oxygen saturation values measurement at twelve points.
Measured: Baseline and peroperative measurements until the and of surgery
Baseline arterial blood gas analysis
The baseline arterial blood gas sample taken from the patient after arterial cannulation
Measured: Within 5 minutes after arterial cannulation for the baseline measurement
Venous blood gas analysis
Venous blood gas sample taken from the patient after central jugular venous cannulation
Measured: Within 5 minutes after central jugular venous cannulation
Baseline activated clotting time measurement
The baseline measurement of activated clotting time after arterial cannulation
Measured: Within 5 minutes after arterial cannulation for the baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start12 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Oxygen SaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuna Şahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuna Şahin, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228546
- Sponsor's protocol ID
- Adana City TRH
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahin T, Karaca S. Effects of patient demographic and clinical data on the assessment of cerebral oxygen monitoring values during coronary artery bypass grafting. Perfusion. 2026 Oct 19:2676591261499535. doi: 10.1177/02676591261499535. Online ahead of print.
PubMed 42897937
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Demographic and Clinical Data of Patients on the Assessment of Cerebral Oxygen Monitoring Values Applied During Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07228546
- Acronym / sponsor ID
- Adana City TRH
- Conditions
- Cerebral Oxygen Saturation
- Keywords
- near infrared spectroscopy, coronary artery bypass grafting, regional cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tuna ŞahinUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective coronary artery bypass grafting surgery
Key inclusion criteria (3 listed)
- Accepting to participate in the study
- Undergoing elective coronary artery bypass grafting surgery
- Age 25-80 years Ejection fraction 30% and above
Key exclusion criteria (8 listed)
- Non volunteers
- Age <25 or >80 years
- Ejection fraction below 30%
- Patients with history of neurological disease or neurosurgery
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional oxygen saturation values
Time frame: Baseline and peroperative measurements until the and of surgery
Regional oxygen saturation values measurement at twelve points.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 42897937Sahin T, Karaca S. Effects of patient demographic and clinical data on the assessment of cerebral oxygen monitoring values during coronary artery bypass grafting. Perfusion. 2026 Oct 19:2676591261499535. doi: 10.1177/02676591261499535. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygen Saturation, run by Tuna Şahin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional oxygen saturation values (time frame: Baseline and peroperative measurements until the and of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07228546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.