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Trial record 8 of 619 for:    oximeter

Comparison of Central 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. Identifier: NCT01788956
Recruitment Status : Unknown
Verified September 2015 by Mespere Lifesciences Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):
Mespere Lifesciences Inc.

Brief 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

Condition or disease Intervention/treatment
Sepsis Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy Cardiogenic Shock Post Myocardial Infarction Hypoxemic Respiratory Failure. Device: Mespere Venous Oximeter Device: Co-Oximeter

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Central Venous Oxygen Saturation, Measured by a CO-Oximeter.
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Group/Cohort Intervention/treatment
ICU Patients
80 subjects (male and female)
Device: Mespere Venous Oximeter
Mespere Venous oximeter provides non-invasive measurement of the oxygenation of the venous blood.

Device: Co-Oximeter

Primary Outcome Measures :
  1. Mespere Venous Oximeter Accuracy Verification Study [ Time Frame: up to 36 hours ]

Biospecimen Retention:   Samples With DNA
Whole blood

Information from the National Library of Medicine

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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
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT01788956

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Canada, Ontario
London Health Sciences Center, University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Mespere Lifesciences Inc.
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Principal Investigator: Michael Sharpe, MD, FRCPC LHSC University Hospital

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Responsible Party: Mespere Lifesciences Inc. Identifier: NCT01788956     History of Changes
Other Study ID Numbers: MLS STP-9100002
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Mespere Lifesciences Inc.:
venous oximeter
ICU Patients
non-invasive device
Additional relevant MeSH terms:
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Respiratory Insufficiency
Myocardial Infarction
Shock, Cardiogenic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases