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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-06-30

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.

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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.

Conditions

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Validation of Oximeter System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure Patients

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

Mespere Venous Oximeter

Intervention Type DEVICE

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

Avoximeter 4000

Intervention Type DEVICE

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.

Interventions

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Mespere Venous Oximeter

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

Intervention Type 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No