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

Mespere Lifesciences

Status: Completed

Conditions: Validation of Oximeter System

Treatments: Device: Mespere Venous Oximeter; Device: Avoximeter 4000

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01908790

HUM00075160

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

17 participants in 1 patient group

Heart Failure Patients

Description:

Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care

Treatment:

Device: Mespere Venous Oximeter

Device: Avoximeter 4000