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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01908790

Enrollment

Registered

2013-07-26

Start date

2013-07-31

Completion date

2015-06-30

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation of Oximeter System

Keywords

venous oximeter, non-invasive monitor, heart failure (HF)

Brief summary

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

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.

Interventions

DEVICEMespere Venous Oximeter

The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.

DEVICEAvoximeter 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter	0-10 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026