Clinical trial NCT00151307: Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes
Official title: The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cardiovascular Diseases
Postoperative Complications
Keywords: Heart surgery
Cerebral oxygen saturation
Neuropsychological function
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2005-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Neuropsychological Outcome
measure: Tests:
measure: Anti-saccadic eye movement
measure: Mini-mental state examination
measure: Neurological testing
measure: Completed pre-operatively, 3-4 days post-op, 2-3 months post-op
Secondary outcomes:
measure: ICU & Hospital length of stay
measure: Morbidity (complications post-op)
measure: Mortality
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital, Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital
name: Fun-Sun Yao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.