Comparison of Central Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
The intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is currently the standard of care for measuring SvO2
Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy
Cardiogenic Shock Post Myocardial Infarction
Hypoxemic Respiratory Failure.
Device: Mespere VA Oximeter
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Central Venous Oxygen Saturation (ScvO2), Measured by a CO-Oximeter.|
- ScvO2 Accuracy Verification Study [ Time Frame: up to 36 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
80 subjects (male and female)
Device: Mespere VA Oximeter
Mespere VA oximeter provides non-invasive measurement of the oxygenation of the venous blood. In the measurement, the venous adhesive patch is placed on top of the internal or external jugular vein (right or left). The monitor simultaneously displays the oxygenation and plethysmographic waveform of the venous blood.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 novel non-invasive medical device for simultaneous monitoring of venous blood oxygenation through the internal or external jugular vein. The Mespere VA Oximeter is based upon near infrared spectroscopy. The System consists of a portable monitor and probe is placed on the skin overlying the internal or external jugular vein (right or left). The monitor displays the oxygenation and plethysmographic waveforms of venous blood measured at the level of the neck vein.
Continuous measurement of SvO2 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788956
|Contact: Melissa T Perri, MESc||519-884-7575 ext firstname.lastname@example.org|
|London Health Sciences Center, University Hospital||Not yet recruiting|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator: Michael Sharpe, MD, FRCPC|
|Principal Investigator:||Michael Sharpe, MD, FRCPC||LHSC University Hospital|