A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00598936|
Recruitment Status : Terminated (Investigator considered the device with no clinical utility.)
First Posted : January 23, 2008
Last Update Posted : September 5, 2011
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Heart Valve Disease||Device: CDI 1000 COM and INVOS 5100|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Cardiac Surgery or Hospitalization
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598936
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Jeffrey C Milliken, MD||University of California, Irvine|