Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

Phase 2

Terminated

• Conditions: Cardiovascular Diseases; Postoperative Complications

• Registration Number: NCT00151307
• Lead Sponsor: Weill Medical College of Cornell University

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).

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Study Completion: 2007-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-05
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anti-saccadic eye movement
Mini-mental state examination
Neurological testing
Neuropsychological Outcome
Tests:
Completed pre-operatively, 3-4 days post-op, 2-3 months post-op

Secondary Outcome Measures

Name	Time	Method
ICU & Hospital length of stay
Morbidity (complications post-op)
Mortality

Trial Locations

Locations (1)

New York Presbyterian Hospital, Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States