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Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Cardiovascular Diseases Postoperative Complications | Device: INVOS cerebral oximeter | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
- 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
- ICU & Hospital length of stay
- Morbidity (complications post-op)
- Mortality
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2001 |
| Estimated Study Completion Date: | April 2007 |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00151307
| United States, New York | |
| New York Presbyterian Hospital, Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| 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 |
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 June 26, 2017