Cognitive Functions on Coronary Surgery

The Effect of Intraoperative Arterial Oxygen Levels on Cognitive Functions After Coronary Bypass Graft Surgery

The aim of this study is to examine the effects of different but safe levels of arterial oxygen levels used in cardiac surgeries on cerebral oxygenation during the operation. It is also to investigate the effect on cognitive functions in the postoperative period. For our study the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups according to the arterial oxygen levels.If there is any abnormality in cerebral oxygen levels during surgery, necessary intervention will be made by doctors.

Study Overview

• Status: Completed
• Conditions: Neurocognitive Disorders
• Intervention / Treatment: Procedure: procedure: cerebral oxygenation intervention

Detailed Description

In most cardiovascular surgeries, patients are frequently followed up at hyperoxemic level for safety purposes against the risk of tissue hypoxia that may develop during surgery due to CPB use. At the level of hyperoxemia, there are opinions that the ischemia-reperfusion damage increases with the follow-up of CABG surgery, microcirculation is impaired and tissue oxygenation is impaired due to the resulting hyperoxemic vasoconstriction. Recent research has focused on evaluating optimal oxygen levels in CPB during cardiac surgery. However, the potential of tightly regulated intraoperative normoxia to improve POCD following cardiac surgery has not been studied prospectively.

The purpose of this study is to determine whether patients who underwent CPB and CABG, which were preserved under normoxic conditions during the intraoperative period, would have a lower incidence of early and late POCD than those exposed to hyperoxia.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16200
    • Bursa YIERH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery

Exclusion Criteria:

• severe preoperative cognitive impairment(i.e. dementia, intellectual disorder)
• Non-Turkish speaking patients
• presence of end-stage organ failure
• patients requiring emergency coronary surgery
• surgical procedures requiring single lung ventilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: normoxy; Group 1(n=50) FiO2%40, PaO2<180 ve PaO2≥80mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored. An rSO2 less than 45% triggered an alarm, the anesthesiologist timed the event, and after 60 seconds initiated an intervention protocol means; PaO2 levels were checked, PaO2> 100 mmHg was achieved, if not improved, pump blood flow, mean arterial pressure were increased, if there is still no response and hematocrit <20%, patients were scheduled for erythrocyte transfusion until the rSO2 was restored to at least 60% at both probes.In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.	Procedure: procedure: cerebral oxygenation intervention; During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.
Experimental: hyperoxia; Group 2(n=50) FiO2%100, PaO2≥180mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored..In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.	Procedure: procedure: cerebral oxygenation intervention; During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	12 hours after surgery
postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	24 hours after surgery
postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	1 month after surgery
postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	3 months after surgery
postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation time after surgery	Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery	During the hospitalization for postoperative recovery ,average 8 days

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Chair: Halil Erkan H SAYAN, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Filiz F ATA, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Canan C YILMAZ, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Ayşe Neslihan AN BALKAYA, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Cüneyt C ERİŞ, Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular surgery; cerebral oxymetre; neurocognitive assessment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: Bursa YIERH

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