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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

June 9, 2009
August 3, 2012
June 2009
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00917124 on ClinicalTrials.gov Archive Site
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 ]
evidence of comma, 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 ]
Not Provided
Not Provided
 
Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients
Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Coronary Artery Bypass Graft Surgery
  • Postoperative Cognitive Dysfunction
  • Neurological Impairment
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)
  • Active Comparator: INVOS
    Intervention: Device: INVOS
  • No Intervention: CONTROL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT00917124
KAI-AKA01
No
Zeljko Colak, University of Zagreb
University of Zagreb
Not Provided
Principal Investigator: Zeljko Colak, MD University Hospital Center Zagreb
University of Zagreb
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP