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Trial record 78 of 619 for:    oximeter

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
Sponsor:
Collaborator:
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Emily Methangkool, MD, MPH, University of California, Los Angeles

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

Condition or disease
Cardiac Surgical Patients

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.


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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiothoracic surgical population at UCLA
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Scovotti, M.A. 310.206.4484 jscovotti@mednet.ucla.edu

Locations
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United States, California
Ronald Reagan UCLA Medical Center, Department of Anesthesiology Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Emily Methangkool, MD, MPH         
Sponsors and Collaborators
University of California, Los Angeles
CAS Medical Systems, Inc.
Investigators
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Principal Investigator: Emily Methangkool, MD, MPH University of California, Los Angeles

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Responsible Party: Emily Methangkool, MD, MPH, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02426268     History of Changes
Other Study ID Numbers: FORE-SIGHT 13-000448
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Keywords provided by Emily Methangkool, MD, MPH, University of California, Los Angeles:
cardiac surgery
cerebral oximetry
lower extremity oximetry