- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01908790
Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Venous Oxygen Saturation From Blood Samples From the Jugular Vein vs Central Venous Oxygen Saturation vs Mixed Venous Oxygen Saturation, Measured by a CO-Oximeter.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures arterial blood oxygenation. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.
The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-Oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to critically ill patients.
By non-invasively monitoring venous blood oxygenation, the Mespere Oximeter provides more complete information on patient hemodynamics.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States
- University of Michigan Cardiovascular Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
Exclusion Criteria:
- Lack of patient consent
- Subject is pregnant
- Evidence of abnormal neck anatomy
- Subject does not have visible left and right jugular veins
- Subject has occluded internal jugular veins under ultrasound imaging
- Allergic to adhesive tape
- Ongoing photodynamic therapy
- Presence of known anatomical shunt or AV dialysis fistula
- Known central vein stenosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Heart Failure Patients
Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
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The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.
The portable Avoximeter 4000 provides rapid, accurate assessment of the patient's true oxygenation status at the bedside.
Features: Results in less than 10 seconds; No sample preparation required; Uses whole blood sample; Easy to use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter
Time Frame: 0-10 minutes
|
0-10 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HUM00075160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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