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FORE-SIGHT Tissue Oximeter During Cardiac Surgery

NCT ID: NCT02426268

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-11-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiac Surgical Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CAS Medical Systems, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Emily Methangkool, MD, MPH

Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Methangkool, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Ronald Reagan UCLA Medical Center, Department of Anesthesiology

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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FORE-SIGHT 13-000448

Identifier Type: -

Identifier Source: org_study_id