Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
1 other identifier
observational
17
1 country
1
Brief Summary
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 18, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 28, 2015
September 1, 2015
1.9 years
July 18, 2013
September 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter
0-10 minutes
Study Arms (1)
Heart Failure Patients
Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
Interventions
The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.
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.
Eligibility Criteria
Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
You may qualify if:
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mespere Lifesciences Inc.lead
- University of Michigancollaborator
Study Sites (1)
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd M Koelling, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2013
First Posted
July 26, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 28, 2015
Record last verified: 2015-09