Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

Cardiovascular Diseases Clinical Trial

Official title: The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery

Status Terminated

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Postoperative Complications

• NCT number: NCT00151307
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: February 2001
• Completion date: April 2007