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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Mespere Lifesciences Inc.
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01788956
First received: February 7, 2013
Last updated: October 6, 2014
Last verified: August 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Mespere Lifesciences Inc.:

Primary Outcome Measures:
  • Mespere Venous Oximeter Accuracy Verification Study [ Time Frame: up to 36 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 40
Study Start Date: October 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788956

Contacts
Contact: Melissa T Perri, MESc 519-884-7575 ext 2 melissa.perri@mespere.com

Locations
Canada, Ontario
London Health Sciences Center, University Hospital Not yet recruiting
London, Ontario, Canada, N6A 5A5
Principal Investigator: Michael Sharpe, MD, FRCPC         
Sponsors and Collaborators
Mespere Lifesciences Inc.
Investigators
Principal Investigator: Michael Sharpe, MD, FRCPC LHSC University Hospital
  More Information

No publications provided

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01788956     History of Changes
Other Study ID Numbers: MLS STP-9100002
Study First Received: February 7, 2013
Last Updated: October 6, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Mespere Lifesciences Inc.:
venous oximeter
CO-Oximeter
ICU Patients
Sepsis
non-invasive device

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Respiratory Insufficiency
Shock, Cardiogenic
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Shock
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014