Coronary Artery Disease, Heart Valve Disease
Conditions
Keywords
Hypoxia, Cerebral Hypoxia
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.
Interventions
DEVICECDI 1000 COM and INVOS 5100
CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement.
Sponsors
University of California, Irvine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. To be 18 years old or older 2. Scheduled for cardiac surgery 3. Treatment will include 72 hours or more of hospital stay 4. 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
1. History of cerebrovascular disease 2. History of skin problems on forehead (skin rashes, acne, allergies, etc.) 3. History of craniofacial surgeries 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test a new device for Cerebral Oxygenation Monitoring | 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety of human forehead skin during period of probe adhesion | 12 hours |
Countries
United States
Outcome results
None listed