Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01583634
First received: April 12, 2012
Last updated: August 14, 2014
Last verified: August 2014

April 12, 2012
August 14, 2014
September 2014
September 2014   (final data collection date for primary outcome measure)
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter [ Time Frame: approximately 1 hour ] [ Designated as safety issue: No ]
SpO2 Accuracy Verification Study, SpO2 between 70% & 100% [ Time Frame: approximately 1 hour ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01583634 on ClinicalTrials.gov Archive Site
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Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

This study is designed to calibrate and validate the Mespere VA Oximeter against a CO-Oximeter on healthy volunteers.

Mespere VA Oximeter is a novel non-invasive medical device for monitoring of venous blood oxygenation through the right external jugular vein.

The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many clinical situations where tissue hypoxia may exist despite normal values obtained by conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand (i.e. venous oxygen saturation) of the tissues. The aim of monitoring tissue hypoxia can be achieved by monitoring the balance between oxygen supply (via arterial oxygen saturation) and oxygen demand (via venous oxygen saturation).

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. Furthermore, there is the need for catheter recalibration against a CO-oximeter every 4- 6 hours. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to those critically ill patients. 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.

By non-invasively monitoring venous blood oxygenation, Mespere VA Oximeter provides more complete information on patient hemodynamics.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones

Healthy Volunteers
  • Device: Mespere VA Oximeter
    Mespere VA oximeter provides non-invasive measurement of the oxygenation of the venous blood. In the measurement, the venous adhesive patch is placed on top the right external jugular vein. The monitor displays the oxygenation and plethysmographic waveform of the venous blood.
  • Device: Radiometer OSM-3 Co-Oximeter
    OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin. Using a small sample of 35ul, the Radiometer OSM-3 hemoximeter is capable of measuring 6 parameters such as sO2, ctHb, FO2Hb, FCOHb, FMetHb, and FHHb.
Healthy volunteers
9 subjects (male and female)
Interventions:
  • Device: Mespere VA Oximeter
  • Device: Radiometer OSM-3 Co-Oximeter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
9
October 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers between the ages of 21 and 49 years of either gender

Exclusion Criteria:

  • smokers
  • pregnancy
  • any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease
  • obesity
  • evidence of abnormal neck vein anatomy
Both
21 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01583634
MLS STP-9100001, MESP05
No
Mespere Lifesciences Inc.
Mespere Lifesciences Inc.
Not Provided
Principal Investigator: Philip E Bickler, MD, PhD University of California, San Francisco
Mespere Lifesciences Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP