Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

This study has been terminated.
(Could not recruit any more people.)
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151307
First received: September 6, 2005
Last updated: June 5, 2008
Last verified: June 2008

September 6, 2005
June 5, 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 ClinicalTrials.gov Archive Site
  • ICU & Hospital length of stay
  • Morbidity (complications post-op)
  • Mortality
Same as current
Not Provided
Not Provided
 
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).

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151307
0599-691
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