Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients
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| ClinicalTrials.gov Identifier: NCT00917124 |
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Recruitment Status :
Completed
First Posted : June 10, 2009
Results First Posted : August 7, 2013
Last Update Posted : July 8, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease Postoperative Cognitive Dysfunction Neurological Impairment | Device: INVOS | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study |
| Study Start Date : | June 2009 |
| Actual Primary Completion Date : | September 2010 |
| Actual Study Completion Date : | September 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: INVOS
INVOS : Cerebral oxygenation (rSO2) monitoring with INVOS. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of 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.
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Device: INVOS
Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur it can be responded with simple interventions to prevent a brain injury including: repositioning of the head or perfusion cannulae to avoid mechanical obstruction of cerebral blood flow, increasing arterial carbon dioxide tension within normal referent values, increasing oxygen inspiration concentration to maintain adequate tissue oxygen saturation, increasing arterial blood pressure, pump flow rate and cardiac index, temperature decreasing and increasing of anesthetic depth to reduce cerebral oxygen consumption and blood transfusion if hematocrit decreases below 22%. None of the interventions are outside the range of good clinical practice. Other Names:
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No Intervention: CONTROL
The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
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- 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
- 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 [ Time Frame: 7 postoperative days ]
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- Dialysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917124
| Croatia | |
| University Hospital Center Zagreb | |
| Zagreb, Croatia, 10000 | |
| Principal Investigator: | Zeljko Colak, MD | Clinical Hospital Centre Zagreb |
| Responsible Party: | Zeljko Colak, Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study, University of Zagreb |
| ClinicalTrials.gov Identifier: | NCT00917124 |
| Other Study ID Numbers: |
KAI-AKA01 |
| First Posted: | June 10, 2009 Key Record Dates |
| Results First Posted: | August 7, 2013 |
| Last Update Posted: | July 8, 2015 |
| Last Verified: | June 2015 |
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cerebral oximetry NIRS INVOS |
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Coronary Artery Disease Postoperative Cognitive Complications Cognitive Dysfunction Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders Postoperative Complications Pathologic Processes |