Clinical trial NCT04725708: Cognitive Functions on Coronary Surgery
Official title: The Effect of Intraoperative Arterial Oxygen Levels on Cognitive Functions After Coronary Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurocognitive Disorders
Keywords: cardiovascular surgery
cerebral oxymetre
neurocognitive assessment
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative neurocognitive function
timeFrame: 12 hours after surgery
measure: postoperative neurocognitive function
timeFrame: 24 hours after surgery
measure: postoperative neurocognitive function
timeFrame: 1 month after surgery
measure: postoperative neurocognitive function
timeFrame: 3 months after surgery
measure: postoperative neurocognitive function
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Extubation time after surgery
timeFrame: During the hospitalization for postoperative recovery ,average 8 days
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa YIERH
Study officials:
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Tuğba T ONUR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Ümran Ü KARACA, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Filiz F ATA, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Halil Erkan H SAYAN, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Anıl A ONUR, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Canan C YILMAZ, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Ayşe Neslihan AN BALKAYA, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Cüneyt C ERİŞ
role: STUDY_CHAIR
References: