Comparison of Central Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
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|ClinicalTrials.gov Identifier: NCT01788956|
Recruitment Status : Unknown
Verified September 2015 by Mespere Lifesciences Inc..
Recruitment status was: Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment|
|Sepsis Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy Cardiogenic Shock Post Myocardial Infarction Hypoxemic Respiratory Failure.||Device: Mespere Venous Oximeter Device: Co-Oximeter|
The conventional bedside pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring and measures arterial blood oxygenation. To date, a non-invasive bedside monitor for measuring mixed venous oxygen saturation (SvO2) has not been developed. The clinical applications of venous oximetry are numerous and include management of severe sepsis and septic shock, trauma and hemorrhagic shock, 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 through a central venous catheter Oximetry. However, SvO2 measurements using fiber optic catheters are very expensive, and all central line insertions include inherent risks. Also, insertion of a central line is in some circumstances not feasible (e.g. discomfort/limited experience in central line insertion, unavailability of specific monitoring systems etc.) resulting in inappropriate therapy usually guided by SvO2. Therefore, a non-invasive monitor to measure SvO2 at the bedside negating the requirement for a central line insertion would be of clinical benefit and allow appropriate therapy of many patients listed above at a time when therapy has the most benefit.
The Mespere VA Oximeter is a non-invasive medical device for monitoring of venous blood oxygenation.
Continuous measurement of venous oxygenation will be beneficial because it will help the physician better understand local ischemia as well as provide better guidance for the physician to be able to best treat the patient and decrease their burden of illness.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Central Venous Oxygen Saturation, Measured by a CO-Oximeter.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
80 subjects (male and female)
Device: Mespere Venous Oximeter
Mespere Venous oximeter provides non-invasive measurement of the oxygenation of the venous blood.
- Mespere Venous Oximeter Accuracy Verification Study [ Time Frame: up to 36 hours ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788956
|London Health Sciences Center, University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Michael Sharpe, MD, FRCPC||LHSC University Hospital|