Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
This pilot study is designed to calibrate and validate the Mespere VA Oximeter against a CO-Oximeter on healthy volunteers.
Device: Mespere VA Oximeter
Device: Radiometer OSM-3 Co-Oximeter
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin|
- SpO2 Accuracy Verification Study, SpO2 between 70% & 100% [ Time Frame: approximately 1 hour ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||April 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
5 subjects (male and female)
Device: Mespere VA Oximeter
Mespere VA oximeter provides non-invasive measurement of the oxygenation of the venous and arterial blood simultaneously. In the measurement, the venous adhesive patch is placed on top the right external jugular vein and the pulse oximeter probe is placed on the right index finger. The monitor simultaneously displays the oxygenations and plethysmographic waveforms of venous blood and arterial 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.
Mespere VA (Venous and Arterial) Oximeter is a novel non-invasive medical device for simultaneous monitoring of venous blood oxygenation through the right external jugular vein and arterial blood oxygenation through the finger tip (SpO2).
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 both venous and arterial blood oxygenation, Mespere VA Oximeter provides more complete information on patient hemodynamics and has clear advantages over conventional pulse oximeters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583634
|United States, California|
|University of California, San Francisco, Induced Hypoxia Lab|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Philip E Bickler, MD, PhD||University of California, San Francisco|