Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients
Condition: Coronary Artery Disease; Postoperative Cognitive Dysfunction; Neurological Impairment
MeSH terms: Coronary Artery Disease; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

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.
    

Intervention name(s): INVOS
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): INVOS (in vivo optical spectroscopy); NIRS (near infrared spectroscopy)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: cerebral oximetry; NIRS; INVOS