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
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Postoperative Complications
Device: INVOS cerebral oximeter
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • ICU & Hospital length of stay
  • Morbidity (complications post-op)
  • Mortality

Estimated Enrollment: 200
Study Start Date: February 2001
Estimated Study Completion Date: April 2007
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151307

Locations
United States, New York
New York Presbyterian Hospital, Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
Investigators
Principal Investigator: Fun-Sun Yao, M.D. Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00151307     History of Changes
Other Study ID Numbers: 0599-691
Study First Received: September 6, 2005
Last Updated: June 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Heart surgery
Cerebral oxygen saturation
Neuropsychological function

Additional relevant MeSH terms:
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014