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Sponsors and Collaborators: |
Weill Medical College of Cornell University New York Presbyterian Hospital |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00151307 |
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 |
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Cardiovascular Diseases Postoperative Complications |
Device: INVOS cerebral oximeter |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery |
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).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 0599-691 |
Study First Received: | September 6, 2005 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00151307 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart surgery Cerebral oxygen saturation Neuropsychological function |
Postoperative Complications |
Pathologic Processes Postoperative Complications Cardiovascular Diseases |