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Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

Primary Purpose

Cardiovascular Diseases, Postoperative Complications

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

INVOS cerebral oximeter

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Heart surgery, Cerebral oxygen saturation, Neuropsychological function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New York Presbyterian Hospital, Weill Medical College of Cornell University

Outcomes

Primary Outcome Measures

Neuropsychological Outcome

Tests:

Anti-saccadic eye movement

Mini-mental state examination

Neurological testing

Completed pre-operatively, 3-4 days post-op, 2-3 months post-op

Secondary Outcome Measures

ICU & Hospital length of stay

Morbidity (complications post-op)

Mortality

Full Information

NCT ID

NCT00151307

First Posted

September 6, 2005

Last Updated

June 5, 2008

Sponsor

Weill Medical College of Cornell University

Collaborators

New York Presbyterian Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00151307

Brief Title

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

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Terminated

Why Stopped

Could not recruit any more people.

Study Start Date

February 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

New York Presbyterian Hospital

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Postoperative Complications

Keywords

Heart surgery, Cerebral oxygen saturation, Neuropsychological function

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

INVOS cerebral oximeter

Primary Outcome Measure Information:

Title

Neuropsychological Outcome

Title

Tests:

Title

Anti-saccadic eye movement

Title

Mini-mental state examination

Title

Neurological testing

Title

Completed pre-operatively, 3-4 days post-op, 2-3 months post-op

Secondary Outcome Measure Information:

Title

ICU & Hospital length of stay

Title

Morbidity (complications post-op)

Title

Mortality

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fun-Sun Yao, M.D.

Organizational Affiliation

Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Presbyterian Hospital, Weill Medical College of Cornell University

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15578464

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.

Results Reference

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