COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137527
Recruitment Status : Terminated
First Posted : August 30, 2005
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
Atlantic Health System

Brief Summary:
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 or disease Intervention/treatment Phase
Neurological Manifestations Device: Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods

Secondary Outcome Measures :
  1. Relationship of intraoperative risk data to postoperative cognitive function

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 alcohol (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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00137527

Layout table for location information
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Sponsors and Collaborators
Atlantic Health System
Layout table for investigator information
Principal Investigator: James P Slater, MD Morristown Memorial Hospital
Layout table for additonal information
Responsible Party: Atlantic Health System Identifier: NCT00137527    
Other Study ID Numbers: B03-07-008
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014
Keywords provided by Atlantic Health System:
Cardiac Surgery
Cardiopulmonary Bypass
Cerebral Oxygenation
Neurologic Dysfunction
Neurocognitive Dysfunction
Neurological manifestations
Memory loss
Coronary Artery Bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs