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

September 25, 2015 updated by: Mespere Lifesciences Inc.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Failure Patients
Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter
Time Frame: 0-10 minutes
0-10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mespere Lifesciences Inc.

Collaborators

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (ESTIMATE)

July 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00075160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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