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Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Diseases Postoperative Complications Device: INVOS cerebral oximeter Phase 2 Phase 3

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery
Study Start Date : February 2001
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Neuropsychological Outcome
  2. Tests:
  3. Anti-saccadic eye movement
  4. Mini-mental state examination
  5. Neurological testing
  6. Completed pre-operatively, 3-4 days post-op, 2-3 months post-op

Secondary Outcome Measures :
  1. ICU & Hospital length of stay
  2. Morbidity (complications post-op)
  3. Mortality

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00151307


Locations
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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
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Principal Investigator: Fun-Sun Yao, M.D. Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00151307    
Other Study ID Numbers: 0599-691
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008
Keywords provided by Weill Medical College of Cornell University:
Heart surgery
Cerebral oxygen saturation
Neuropsychological function
Additional relevant MeSH terms:
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Cardiovascular Diseases
Postoperative Complications
Pathologic Processes