Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter

Study Overview
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Brief Summary
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The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.

Detailed Description
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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.

Official Title
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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.

Conditions
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Validation of Oximeter System

Intervention / Treatment
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* Device: Mespere Venous Oximeter
* Device: Avoximeter 4000


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure Patients<br>Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care | Device: Mespere Venous Oximeter<br>* The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.<br>Device: Avoximeter 4000<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter |  | 0-10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous oximeter, non-invasive monitor, heart failure (HF)