SepsisNCT01788956
Comparison of Central Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
An observational study of Sepsis and Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, run by Mespere Lifesciences Inc. at 1 site in Canada.
Trial summary
The intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is currently the standard of care for measuring SvO2 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, Cardiogenic Shock Post Myocardial Infarction
- What is being tested?
- Mespere Venous Oximeter and Co-Oximeter
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Oct 2016
- 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: Study subjects will consist of patients admitted either to the Medical Surgical ICU or the Cardiac Surgery Recovery Unit at University Hospital. The four groups will comprise patients with the following diagnoses: i) sepsis +/- septic shock, ii) post cardiac surgery low output syndrome requiring inotropic/vasopressor therapy, iii) cardiogenic shock post myocardial infarction, and iv) hypoxemic respiratory failure.
Who may be able to join
- Age 18 and older
- Patients admitted to the ICU
- Patients who have or are scheduled to have an indwelling central venous catheter inserted via the internal jugular vein or subclavian vein as part of their usual care
Who cannot join
- Abnormal neck anatomy
- Unable to identify jugular vein under ultrasound guidance
- Allergic to adhesive tape
- Presence of known anatomical shunt or AV dialysis fistula
- Known central vein stenosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Center, University Hospital
London, Ontario, N6A 5A5
About this study
Official title: Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Central Venous Oxygen Saturation, Measured by a CO-Oximeter.
The intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is currently the standard of care for measuring SvO2
Read the detailed description
The conventional bedside pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring and measures arterial blood oxygenation. To date, a non-invasive bedside monitor for measuring mixed venous oxygen saturation (SvO2) has not been developed. The clinical applications of venous oximetry are numerous and include management of severe sepsis and septic shock, trauma and hemorrhagic shock, 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 through a central venous catheter Oximetry. However, SvO2 measurements using fiber optic catheters are very expensive, and all central line insertions include inherent risks. Also, insertion of a central line is in some circumstances not feasible (e.g. discomfort/limited experience in central line insertion, unavailability of specific monitoring systems etc.) resulting in inappropriate therapy usually guided by SvO2. Therefore, a non-invasive monitor to measure SvO2 at the bedside negating the requirement for a central line insertion would be of clinical benefit and allow appropriate therapy of many patients listed above at a time when therapy has the most benefit.
The Mespere VA Oximeter is a non-invasive medical device for monitoring of venous blood oxygenation.
Continuous measurement of venous oxygenation will be beneficial because it will help the physician better understand local ischemia as well as provide better guidance for the physician to be able to best treat the patient and decrease their burden of illness.
- Conditions
- Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, Cardiogenic Shock Post Myocardial Infarction, Hypoxemic Respiratory Failure.
- Being tested
- Mespere Venous Oximeter, Co-Oximeter
- Keywords
- venous oximeter, CO-Oximeter, ICU Patients, Sepsis, non-invasive device
- Medical subject headings
- Sepsis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere Venous OximeterDevice
Mespere Venous oximeter provides non-invasive measurement of the oxygenation of the venous blood.
Co-OximeterDevice
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients | 80 subjects (male and female) Receives: Device: Mespere Venous Oximeter; Device: Co-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mespere Venous Oximeter Accuracy Verification Study
Measured: up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Sharpe, MD, FRCPC, Principal investigator, LHSC University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788956
- Sponsor's protocol ID
- MLS STP-9100002
- Status last verified
- Sep 2015
- First submitted
- 7 Feb 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 Central Venous Oxygen Saturation, Measured by a CO-Oximeter.
- ClinicalTrials.gov ID
- NCT01788956
- Acronym / sponsor ID
- MLS STP-9100002
- Conditions
- Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, Cardiogenic Shock Post Myocardial Infarction, Hypoxemic Respiratory Failure.
- Keywords
- venous oximeter, CO-Oximeter, ICU Patients, Sepsis, non-invasive device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 11 Feb 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 intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is currently the standard of care for measuring SvO2
Detailed description
The conventional bedside pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring and measures arterial blood oxygenation. To date, a non-invasive bedside monitor for measuring mixed venous oxygen saturation (SvO2) has not been developed. The clinical applications of venous oximetry are numerous and include management of severe sepsis and septic shock, trauma and hemorrhagic shock, 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 through a central venous catheter Oximetry. However, SvO2 measurements using fiber optic catheters are very expensive, and all central line insertions include inherent risks. Also, insertion of a central line is in some circumstances not feasible (e.g. discomfort/limited experience in central line insertion, unavailability of specific monitoring systems etc.) resulting in inappropriate therapy usually guided by SvO2. Therefore, a non-invasive monitor to measure SvO2 at the bedside negating the requirement for a central line insertion would be of clinical benefit and allow appropriate therapy of many patients listed above at a time when therapy has the most benefit.
The Mespere VA Oximeter is a non-invasive medical device for monitoring of venous blood oxygenation.
Continuous measurement of venous oxygenation will be beneficial because it will help the physician better understand local ischemia as well as provide better guidance for the physician to be able to best treat the patient and decrease their burden of illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients | – | Device: Mespere Venous Oximeter, Device: Co-Oximeter80 subjects (male and female) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will consist of patients admitted either to the Medical Surgical ICU or the Cardiac Surgery Recovery Unit at University Hospital. The four groups will comprise patients with the following diagnoses: i) sepsis +/- septic shock, ii) post cardiac surgery low output syndrome requiring inotropic/vasopressor therapy, iii) cardiogenic shock post myocardial infarction, and iv) hypoxemic respiratory failure.
Key inclusion criteria (3 listed)
- Age 18 and older
- Patients admitted to the ICU
- Patients who have or are scheduled to have an indwelling central venous catheter inserted via the internal jugular vein or subclavian vein as part of their usual care
Key exclusion criteria (5 listed)
- Abnormal neck anatomy
- Unable to identify jugular vein under ultrasound guidance
- Allergic to adhesive tape
- Presence of known anatomical shunt or AV dialysis fistula
- Known central vein stenosis
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 OximeterMespere Venous oximeter provides non-invasive measurement of the oxygenation of the venous blood. | Device | ICU Patients |
| Co-Oximeter | Device | ICU Patients |
Primary outcome
Mespere Venous Oximeter Accuracy Verification Study
Time frame: up to 36 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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.
Michael Sharpe, MD, FRCPC principal investigator
LHSC University Hospital
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 Sepsis and Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, run by Mespere Lifesciences Inc. at 1 site in Canada.
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 5 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: status not confirmed, 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 Canada. 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?
Results are not available in the source record.
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 Venous Oximeter Accuracy Verification Study (time frame: up to 36 hours). 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.