Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- University of Zagreb
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
It is previously reported that the cerebral oxygen desaturation during cardiac surgery is associated with an increased incidence of cognitive impairment. The aim of this study is to determine whether intraoperative monitoring and predetermined interventions protocol to improve cerebral oxygenation during coronary artery bypass surgery provides benefits in neurocognitive functions.
Detailed Description
Neurologic complications are major cause of morbidity following coronary artery bypass graft surgery. The neurologic injuries range in severity from subclinical cognitive changes to fatal brain injury and death. These complications represent a big impact on overall morbidity, and mortality in association with increased costs and length of hospital stay. The social impact is also very important with consequences on patients' quality of life. Several studies reported the incidence of cognitive decline after cardiac surgery that ranges from 30 to 80%. The most common etiologies are embolization and hypoperfusion of the brain. The In Vivo Optical Spectroscopy (INVOS) system uses near-infrared spectroscopy (NIRS) and provides noninvasive and continuous information on changes in regional oxygen saturation of blood in the brain (rSO2). When rSO2 decline occurs it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion. Recent studies reported that intraoperative cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. Neurocognitive function can be assessed with battery of standardized neurocognitive tests. Mini Mental State Examination, Color Trail Test, Grooved Pegboard Test are easy to perform bedside tests that test orientation, registration, attention, calculation, recall, language and complex visual-motor coordination.
Investigators
Zeljko Colak
Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study
University of Zagreb
Eligibility Criteria
Inclusion Criteria
- •All patients with coronary artery disease undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass
Exclusion Criteria
- •Who refuse to participate
- •Previous stroke
- •Preexisting psychiatric disease
- •Significant carotid stenosis
- •Ejection fraction below 25%
- •Reoperations
- •Emergent surgery
Outcomes
Primary Outcomes
Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.
Time Frame: preoperative, 7 days postoperative
The Mini-Mental State Examination (MMSE) total score is calculated by summing the item scores across several aspects of cognition. The maximum possible total score is 30 points. Color Trials Test (CTT) measures sustained visual attention, visual scanning and graphomotor skills. The examiner records the length of time (in seconds) required by the patient to rapidly draw a line connecting the circles numbered 1 through 25 in consecutive order. Grooved-Pegboard test (GP test) is manipulative dexterity test that contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted. The examiner records the time in seconds. Cognitive impairment was defined as a decline in postoperative performance in one or more tests: decrease of MMSE score three points or more from baseline and decrease of one standard deviation or more in performance on CTT 1 and GP tests
Secondary Outcomes
- Evidence of Coma, Stupor, Cerebral Insult, Delirium, Ventilation Longer Than 24 Hours, Myocardial Infarction, Atrial Fibrillation, Dialysis, Reoperation for Bleeding, Infection, Hospital Stay > 7 Days(7 postoperative days)