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

Completed

• Conditions: Validation of Oximeter System
• Interventions: Device: Mespere Venous Oximeter; Device: Avoximeter 4000

• Registration Number: NCT01908790
• Lead Sponsor: Mespere Lifesciences Inc.

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure Patients	Mespere Venous Oximeter	Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
Heart Failure Patients	Avoximeter 4000	Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care

Primary Outcome Measures

Name	Time	Method
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter	0-10 minutes

Trial Locations

Locations (1)

University of Michigan Cardiovascular Center; 🇺🇸 Ann Arbor, Michigan, United States