The purpose of this study is to determine whether intraoperative brain oxygenation monitoring in cardiac surgery patients is effective in reducing postoperative neurologic and neurocognitive dysfunction.

Condition	Intervention
Coronary Artery Bypass Cardiopulmonary bypass Neurological Manifestations	Device: Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion

Further Study Details: 

Primary Outcomes: Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods
Secondary Outcomes: Relationship of intraoperative risk data to postoperative cognitive function
Expected Total Enrollment:  250

This study represents a prospective, randomized assessment of the potential clinical and economic benefit to be derived from the continuous non-invasive monitoring of regional cerebral oxygen saturation (rSO2) during cardiac surgery employing cardiopulmonary bypass (CPB). Previous studies have shown that low rSO2 values obtained during surgery are highly associated with postoperative frontal lobe dysfunction, cognitive declines, disorientation, and other clinical indices of prolonged recovery. Low rSO2 values are thought to reflect the development of tissue hypoxia within susceptible regions of the cerebral cortex during the non-pulsatile perfusion of CPB. Rapid detection and correction of such episodes should help avoid regional hypoxia and its attendant postoperative sequelae. This study will assess neurologic, psychometric, and quality of life markers of brain dysfunction which could result from CPB. Each study patient will be assessed both pre- and postoperatively (pre-hospital discharge and at three months) for neurologic and neurocognitive dysfunction.

Comparison(s): Intervention versus control group. Patients assigned to the intervention rSO2-monitored group will be managed with conservative measures designed to maintain the rSO2 value at, or above, its preoperative value. Such measures include increases in pump flow, blood pressure, anesthetic dose, arterial oxygen tension, carbon dioxide tension, and hematocrit. Those patients in the control group will be managed according to current established practice. Although rSO2 is also recorded in this group, the monitor''''s readings are blinded.

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Primary Coronary Artery Bypass Surgery
• Ages 18-90
• Voluntary participation with signed informed consent

Exclusion Criteria:

• An unwillingness to participate in the study
• Inability to obtain informed consent
• Expressive or Receptive aphasia
• Inability to correctly perform the neurocognitive tests preoperatively
• Inability to correctly perform the saccadic and anti-saccadic eye movement tests preoperatively
• Non-English speaking candidates
• Patients for whom it is known that follow-up will be improbable
• Previous cardiac surgery
• Concomitant procedures
• Pre-existing psychotic disorders
• Patients with active ETOH abuse requiring emergent surgery
• Patients scoring 2 or higher on the CAGE evaluation
• Mini-Mental State Exam preoperative score of 23 or less
• Severe visual or auditory disorders
• Parkinson''''s disease

Please refer to this study by ClinicalTrials.gov identifier  NCT00137527

Kateki U Vinod, BA      973-971-7324    kateki.vinod@ahsys.org
Theresa Guarino, RN      973-971-6604    theresa.guarino@ahsys.org

New Jersey
      Morristown Memorial Hospital, Morristown,  New Jersey,  07962,  United States; Recruiting

Study chairs or principal investigators

James P Slater, MD,  Principal Investigator,  Morristown Memorial Hospital   

Study ID Numbers:  B03-07-008
Last Updated:  August 29, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00137527
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30