Cardiac Surgical PatientsFORE-SIGHTNCT02426268
FORE-SIGHT Tissue Oximeter During Cardiac Surgery
An observational study of Cardiac Surgical Patients, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Patients
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 21 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiothoracic surgical population at UCLA
Who may be able to join
- Subjects where cerebral oximetry is monitored during their surgery
Who cannot join
- Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center, Department of Anesthesiology
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Surgical Patients
- Keywords
- cardiac surgery, cerebral oximetry, lower extremity oximetry
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Oxygen Saturation
Two sensors from FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows to continuously monitor cerebral oxygen saturation.
Measured: Duration of the surgery (~5-7 hours)
Secondary outcomes (1)
Non-Cerebral Oxygen Saturation
Two sensors from FORE-SIGHT Elite monitor will be placed on the leg muscles to continuously monitor non-cerebral/skeletal muscle oxygen saturation.
Measured: Duration of the surgery (~5-7 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMay 2014
- Primary completion6 Jun 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical PatientsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- CAS Medical Systems, Inc.
- Responsible party
- Principal investigator, Emily Methangkool, MD, MPH, University of California, Los Angeles
- Investigators
- Emily Methangkool, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426268
- Sponsor's protocol ID
- FORE-SIGHT 13-000448
- Acronym
- FORE-SIGHT
- Status last verified
- Nov 2020
- First submitted
- 21 Apr 2015
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02426268
- Acronym / sponsor ID
- FORE-SIGHT / FORE-SIGHT 13-000448
- Conditions
- Cardiac Surgical Patients
- Keywords
- cardiac surgery, cerebral oximetry, lower extremity oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- CAS Medical Systems, Inc.
- Study start
- May 2014 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiothoracic surgical population at UCLA
Key inclusion criteria (1 listed)
- Subjects where cerebral oximetry is monitored during their surgery
Key exclusion criteria (1 listed)
- Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Non-Cerebral Oxygen Saturation
Time frame: Duration of the surgery (~5-7 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Methangkool, MD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Patients, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Oxygen Saturation (time frame: Duration of the surgery (~5-7 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.