An observational study in Coronary Artery Disease and Heart Valve Disease, sponsored by University of California, Irvine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-05.
Sponsored by University of California, Irvine · Observational
The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 21 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult subjects ≥18 year-old of age admitted to the University Hospital setting scheduled for cardiac surgery or admitted for any cause to the Intensive Care Unit (ICU).
Exclusion Criteria:
Patients scheduled for a Cardiac Surgery procedure, two types of cerebral oximetry devices were compared at the same time during the surgical procedure. The second group were patients hospitalized (in the Intensive Care Unit or ICU, with any diagnosis, excluding head trauma patients. Those patients were monitored using two types of cerebral oximetry devices at the same time for up to 72 hours.
Device: CDI 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.
Also known as: Terumo CDI 1000 COM, Somanetics INVOS 5100
To test a new device for Cerebral Oxygenation Monitoring
Time frame: 12 hours
Safety of human forehead skin during period of probe adhesion
Time frame: 12 hours
This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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University of California, Irvine