Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 621 for:    oximeter

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01908790
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : September 28, 2015
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Validation of Oximeter System Device: Mespere Venous Oximeter Device: Avoximeter 4000

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Study Start Date : July 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  1. Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter [ Time Frame: 0-10 minutes ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908790


Locations
Layout table for location information
United States, Michigan
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States
Sponsors and Collaborators
Mespere Lifesciences Inc.
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Todd M Koelling, MD University of Michigan

Layout table for additonal information
Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01908790     History of Changes
Other Study ID Numbers: HUM00075160
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Mespere Lifesciences Inc.:
venous oximeter
non-invasive monitor
heart failure (HF)