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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: August 3, 2012
Last verified: August 2012
History of Changes
  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 Bypass Graft Surgery
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:

U.S. FDA Resources

Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • measure of changes between preoperative and postoperative cognitive functions by standardized tests: MMSE, Color Trail Test, Grooved Pegboard Test [ Time Frame: preoperative, 7 days postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evidence of coma, cerebral insult, behavior impairment, disorientation, ventilation longer than 24 hours, myocardial infarction, significant arrhythmia, dialysis, reoperation for bleeding, any other surgery, wound infection, ICU stay, hospital stay [ Time Frame: until discharge from hospital ] [ 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 Device: INVOS
Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) 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.
Other Names:
  • INVOS (in vivo optical spectroscopy)
  • NIRS (near infrared spectroscopy)
No Intervention: CONTROL

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 INVOS (in vivo optical spectroscopy) 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 on bypass CABG

Exclusion Criteria:

  • Who refuse to participate
  • Previous stroke
  • Preexisting psychiatric disease
  • Significant carotid stenosis
  • Reoperations
  • Emergent surgery
  • Dialysis
  Contacts and Locations
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
Last Updated: August 3, 2012
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Zagreb:
cerebral oximetry
NIRS
INVOS

Additional relevant MeSH terms:
Cognition Disorders
Neurologic Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013