- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151307
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- New York Presbyterian Hospital, Weill Medical College of Cornell University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Mortality
|
ICU & Hospital length of stay
|
Morbidity (complications post-op)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fun-Sun Yao, M.D., Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0599-691
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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