NCT07228546

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

September 30, 2025

Last Update Submit

January 4, 2026

Conditions

Keywords

near infrared spectroscopycoronary artery bypass graftingregional cerebral oxygen saturation

Outcome Measures

Primary Outcomes (4)

  • Regional oxygen saturation values

    Regional oxygen saturation values measurement at twelve points.

    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

    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

    Within 5 minutes after central jugular venous cannulation

  • Baseline activated clotting time measurement

    The baseline measurement of activated clotting time after arterial cannulation

    Within 5 minutes after arterial cannulation for the baseline measurement

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective coronary artery bypass grafting surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuna Şahin

Adana, Yüreğir, 01370, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 30, 2025

First Posted

November 14, 2025

Study Start

May 12, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations