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Clinical Trials/NCT04725708
NCT04725708
Completed
N/A

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

Bursa Yüksek İhtisas Education and Research Hospital1 site in 1 country100 target enrollmentNovember 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neurocognitive Disorders
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Enrollment
100
Locations
1
Primary Endpoint
postoperative neurocognitive function
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
August 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tugba Onur

Principal investigator

Bursa Yüksek İhtisas Education and Research Hospital

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

Outcomes

Primary Outcomes

postoperative neurocognitive function

Time Frame: 6 months after surgery

Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

Secondary Outcomes

  • Extubation time after surgery(During the hospitalization for postoperative recovery ,average 8 days)

Study Sites (1)

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