Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT00137527|
Recruitment Status : Terminated
First Posted : August 30, 2005
Last Update Posted : January 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Neurological Manifestations||Device: Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||250 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Prospective, Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery|
|Study Start Date :||February 2004|
|Actual Study Completion Date :||February 2009|
- Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods
- Relationship of intraoperative risk data to postoperative cognitive function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137527
|United States, New Jersey|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962|
|Principal Investigator:||James P Slater, MD||Morristown Memorial Hospital|