NCT01908790

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
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Mespere Lifesciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Validation of Oximeter System

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-07-26
• Last updated: 2015-09-28

Locations

1 site across 1 country: United States