Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
|ClinicalTrials.gov Identifier: NCT01908790|
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment|
|Validation of Oximeter System||Device: Mespere Venous Oximeter Device: Avoximeter 4000|
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 :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||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 Start Date :||July 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Heart Failure Patients
Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
Device: Mespere Venous Oximeter
The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.
Device: Avoximeter 4000
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.
- Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter [ Time Frame: 0-10 minutes ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908790
|United States, Michigan|
|University of Michigan Cardiovascular Center|
|Ann Arbor, Michigan, United States|
|Principal Investigator:||Todd M Koelling, MD||University of Michigan|