Status:
TERMINATED
Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
Lead Sponsor:
Atlantic Health System
Conditions:
Neurological Manifestations
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether intraoperative brain oxygenation monitoring in cardiac surgery patients is effective in reducing postoperative neurologic and neurocognitive dysfuncti...
Detailed Description
This study represents a prospective, randomized assessment of the potential clinical and economic benefit to be derived from the continuous non-invasive monitoring of regional cerebral oxygen saturati...
Eligibility Criteria
Inclusion
- Primary coronary artery bypass surgery
- Ages 18-90
- Voluntary participation with signed informed consent
Exclusion
- An unwillingness to participate in the study
- Inability to obtain informed consent
- Expressive or receptive aphasia
- Inability to correctly perform the neurocognitive tests preoperatively
- Inability to correctly perform the saccadic and anti-saccadic eye movement tests preoperatively
- Non-English speaking candidates
- Patients for whom it is known that follow-up will be improbable
- Previous cardiac surgery
- Concomitant procedures
- Pre-existing psychotic disorders
- Patients with active alcohol (ETOH) abuse requiring emergent surgery
- Patients scoring 2 or higher on the CAGE evaluation
- Mini-Mental State Exam preoperative score of 23 or less
- Severe visual or auditory disorders
- Parkinson's disease
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00137527
Start Date
February 1 2004
End Date
February 1 2009
Last Update
January 17 2014
Active Locations (1)
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1
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962