Validation of Oximeter SystemNCT01908790
Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
An observational study of Validation of Oximeter System, run by Mespere Lifesciences Inc. at 1 site in United States.
Trial summary
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation of Oximeter System
- What is being tested?
- Mespere Venous Oximeter and Avoximeter 4000
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
Who may be able to join
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
Who cannot join
- 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
Show all 9Show fewer
- Ongoing photodynamic therapy
- Presence of known anatomical shunt or AV dialysis fistula
- Known central vein stenosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cardiovascular Center
Ann Arbor, Michigan
About this study
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.
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.
Read the 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.
- Conditions
- Validation of Oximeter System
- Being tested
- Mespere Venous Oximeter, Avoximeter 4000
- Keywords
- venous oximeter, non-invasive monitor, heart failure (HF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere Venous OximeterDevice
The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.
Avoximeter 4000Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients | Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care Receives: Device: Mespere Venous Oximeter; Device: Avoximeter 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter
Measured: 0-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Oximeter SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Todd M Koelling, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908790
- Sponsor's protocol ID
- HUM00075160
- Status last verified
- Sep 2015
- First submitted
- 18 Jul 2013
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01908790
- Acronym / sponsor ID
- HUM00075160
- Conditions
- Validation of Oximeter System
- Keywords
- venous oximeter, non-invasive monitor, heart failure (HF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | – | Device: Mespere Venous Oximeter, Device: Avoximeter 4000Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care
Key inclusion criteria (3 listed)
- Age 18 and older
- Heart failure patients already receiving RHC as part of their usual care
- Signed written and informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mespere Venous OximeterThe Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation. | Device | Heart Failure Patients |
| Avoximeter 4000The 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. | Device | Heart Failure Patients |
Primary outcome
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter
Time frame: 0-10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd M Koelling, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation of Oximeter System, run by Mespere Lifesciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter (time frame: 0-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.