FORE-SIGHT Tissue Oximeter During Cardiac Surgery (FORE-SIGHT)

November 2, 2020 updated by: Emily Methangkool, MD, MPH, University of California, Los Angeles

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiothoracic surgical population at UCLA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of the surgery (~5-7 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of the surgery (~5-7 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

CAS Medical Systems, Inc.

Investigators

  • Principal Investigator: Emily Methangkool, MD, MPH, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 6, 2019

Study Completion (Actual)

November 21, 2019

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FORE-SIGHT 13-000448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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