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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151307
• Other study ID #: 0599-691
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 6, 2005
• Last updated: June 5, 2008
• Start date: February 2001
• Est. completion date: April 2007

Study information

• Verified date: June 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Device:
• INVOS cerebral oximeter

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital, Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological Outcome
Primary	Tests:
Primary	Anti-saccadic eye movement
Primary	Mini-mental state examination
Primary	Neurological testing
Primary	Completed pre-operatively, 3-4 days post-op, 2-3 months post-op
Secondary	ICU & Hospital length of stay
Secondary	Morbidity (complications post-op)
Secondary	Mortality