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Clinical Trials/NCT00598936
NCT00598936
Terminated
Not Applicable

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

University of California, Irvine1 site in 1 country21 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of California, Irvine
Enrollment
21
Locations
1
Primary Endpoint
To test a new device for Cerebral Oxygenation Monitoring
Status
Terminated
Last Updated
14 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
May 2009
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • To be 18 years old or older
  • Scheduled for cardiac surgery
  • Treatment will include 72 hours or more of hospital stay
  • Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

Exclusion Criteria

  • History of cerebrovascular disease
  • History of skin problems on forehead (skin rashes, acne, allergies, etc.)
  • History of craniofacial surgeries

Outcomes

Primary Outcomes

To test a new device for Cerebral Oxygenation Monitoring

Time Frame: 12 hours

Secondary Outcomes

  • Safety of human forehead skin during period of probe adhesion(12 hours)

Study Sites (1)

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