Clinical Trial: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

Brief Summary: The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

Detailed Summary: Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.
Sponsor: University of California, Irvine

Current Primary Outcome: To test a new device for Cerebral Oxygenation Monitoring [ Time Frame: 12 hours ]

Original Primary Outcome: test & confirm various product requirements on Cardiac Surgery and Hospitalized Patients. a) Optimal ergonomic fit & adhesion of Terumo CDI™ 1000 COM Sensor to human forehead for time period up to 72 hours [ Time Frame: 24-72 hours ]

Current Secondary Outcome: Safety of human forehead skin during period of probe adhesion [ Time Frame: 12 hours ]

Original Secondary Outcome: Safety of human forehead skin during period of adhesion of Terumo CDI™ 1000 COM Sensor on human forehead over same time period. Performance Comparison of Terumo CDI™ 1000 COM vs. Somanetics INVOS 5100 oxygen saturation monitoring during cardiac surger [ Time Frame: 24 - 72 hours ]

Information By: University of California, Irvine

Dates:
Date Received: December 24, 2007
Date Started: November 2007
Date Completion:
Last Updated: September 1, 2011
Last Verified: September 2011