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Completed

NCT Number: NCT02426268

FORE-SIGHT Tissue Oximeter During Cardiac Surgery

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

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Key information

Conditions

Cardiac Surgical Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ronald Reagan UCLA Medical Center, Department of Anesthesiology

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • CAS Medical Systems, Inc.

Registry information

Official study title

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

Acronym: FORE-SIGHT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2015
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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