FORE-SIGHT Tissue Oximeter During Cardiac Surgery (FORE-SIGHT)
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|ClinicalTrials.gov Identifier: NCT02426268|
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : October 10, 2019
|Condition or disease|
|Cardiac Surgical Patients|
The purpose of this research study is to collect data from a tissue oximeter device that measures brain oxygen saturation simultaneous with data from the same device that monitors skeletal muscle during cardiac surgery. This monitoring will allow for continuous, non-invasive, and earlier assessment of perfusion abnormalities/hypoperfusion.
Two sensors from the FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows and two additional sensors will be placed on the leg muscles. Data from the FORE-SIGHT Elite monitor will be recorded in addition to clinical and demographic data, which is standard of care during the procedure, for research purposes to look at factors associated with desaturations.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
- Cerebral Oxygen Saturation [ Time Frame: Duration of the surgery (~5-7 hours) ]Two sensors from FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows to continuously monitor cerebral oxygen saturation.
- Non-Cerebral Oxygen Saturation [ Time Frame: Duration of the surgery (~5-7 hours) ]Two sensors from FORE-SIGHT Elite monitor will be placed on the leg muscles to continuously monitor non-cerebral/skeletal muscle oxygen saturation.
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): NCT02426268
|Contact: Jennifer Scovotti, M.A.||firstname.lastname@example.org|
|United States, California|
|Ronald Reagan UCLA Medical Center, Department of Anesthesiology||Recruiting|
|Los Angeles, California, United States, 90095|
|Principal Investigator: Emily Methangkool, MD, MPH|
|Principal Investigator:||Emily Methangkool, MD, MPH||University of California, Los Angeles|