Cardiovascular Diseases, Postoperative Complications
Conditions
Keywords
Heart surgery, Cerebral oxygen saturation, Neuropsychological function
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.
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).
Interventions
DEVICEINVOS cerebral oximeter
Sponsors
New York Presbyterian Hospital
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| ICU & Hospital length of stay | — |
| Morbidity (complications post-op) | — |
| Mortality | — |
Countries
United States
Outcome results
None listed