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FORE-SIGHT Tissue Oximeter During Cardiac Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02426268
Acronym
FORE-SIGHT
Enrollment
55
Registered
2015-04-24
Start date
2014-05-31
Completion date
2019-11-21
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Patients

Keywords

cardiac surgery, cerebral oximetry, lower extremity oximetry

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.

Interventions

None listed

Sponsors

CAS Medical Systems, Inc.
CollaboratorINDUSTRY
University of California, Los Angeles
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Oxygen SaturationDuration 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

MeasureTime frameDescription
Non-Cerebral Oxygen SaturationDuration 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026