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Clinical Trials/NCT02426268
NCT02426268
Completed
Not Applicable

CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery

University of California, Los Angeles1 site in 1 country55 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgical Patients
Sponsor
University of California, Los Angeles
Enrollment
55
Locations
1
Primary Endpoint
Cerebral Oxygen Saturation
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
November 21, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Methangkool, MD, MPH

Assistant Clinical Professor

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Subjects where cerebral oximetry is monitored during their surgery

Exclusion Criteria

  • Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Non-Cerebral Oxygen Saturation(Duration of the surgery (~5-7 hours))

Study Sites (1)

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