Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

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: NCT00151307
Recruitment Status : Terminated (Could not recruit any more people.)
First Posted : September 8, 2005
Last Update Posted : June 6, 2008
New York Presbyterian Hospital
Information provided by:
Weill Medical College of Cornell University

September 6, 2005
September 8, 2005
June 6, 2008
February 2001
Not Provided
  • Neuropsychological Outcome
  • Tests:
  • Anti-saccadic eye movement
  • Mini-mental state examination
  • Neurological testing
  • Completed pre-operatively, 3-4 days post-op, 2-3 months post-op
Same as current
Complete list of historical versions of study NCT00151307 on Archive Site
  • ICU & Hospital length of stay
  • Morbidity (complications post-op)
  • Mortality
Same as current
Not Provided
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Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes
The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery
The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation (over 40%) on patients undergoing cardiac surgery. Effects on neuropsychological outcome, length of ICU stay, and length of hospital stay will be measured.

Central nervous system dysfunction is a major cause of morbidity after cardiac surgery. This study seeks to evaluate the effects of cerebral oxygen saturation on the neuropsychological outcome of cardiac surgery patients. Currently, monitoring of cerebral oxygen saturation levels is not part of routine and standard practice.

Subjects will be assigned to a control and intervention group. Anesthesia and surgery will be performed as per usual standards of care. Patients in both groups will be monitored with an oxygen sensor placed over the forehead. The data will be recorded continuously on a floppy disk. The control group will be treated according to current standard of care; the readings of brain oxygen saturation will not be visible to the clinician. In the intervention group, the reading of brain oxygen saturation will be monitored by the anesthesiologist throughout surgery. Interventions will be performed to maintain cerebral oxygen saturations above 40%. Neuropsychological tests will be completed pre-operatively and at two time points post-operatively. The tests used are the ASEM (antisaccadic eye movement) and the MMSE (mini-mental state examination).

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Postoperative Complications
Device: INVOS cerebral oximeter
Not Provided
Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2007
Not Provided

Inclusion Criteria:

  • Adult patient
  • Elective cardiac surgery with cardiopulmonary bypass
  • Coronary artery disease or valvular heart disease or combination of both
  • Ability and willingness to give informed consent

Exclusion Criteria:

  • Pediatric patients
  • Emergency surgery
  • Unable to understand English
  • Allergic to tape used to attach oxygen sensor
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Not Provided
Not Provided
Weill Medical College of Cornell University
New York Presbyterian Hospital
Principal Investigator: Fun-Sun Yao, M.D. Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital
Weill Medical College of Cornell University
June 2008

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