Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeljko Colak, University of Zagreb
ClinicalTrials.gov Identifier:
NCT00917124
First received: June 9, 2009
Last updated: July 4, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Postoperative Cognitive Dysfunction
Neurological Impairment
Device: INVOS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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:
  • INVOS (in vivo optical spectroscopy)
  • NIRS (near infrared spectroscopy)
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917124

Locations
Croatia
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Investigators
Principal Investigator: Zeljko Colak, MD University Hospital Center Zagreb
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: KAI-AKA01
Study First Received: June 9, 2009
Results First Received: April 9, 2013
Last Updated: July 4, 2013
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Zagreb:
cerebral oximetry
NIRS
INVOS

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cognition Disorders
Neurologic Manifestations
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014