Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
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|ClinicalTrials.gov Identifier: NCT01583634|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 3, 2014
|Condition or disease||Intervention/treatment|
|Healthy Volunteers||Device: Mespere Oximeter Device: Radiometer OSM-3 Co-Oximeter|
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 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. 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.
More complete information on patient hemodynamics can be provided by non-invasively monitoring of venous blood oxygenation.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2014|
9 subjects (male and female)
Device: Mespere Oximeter
Mespere oximeter provides non-invasive venous blood oxygen saturation.
Device: Radiometer OSM-3 Co-Oximeter
OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.
- Venous Oxygen Saturation Accuracy Verification against Co-Oximeter [ Time Frame: approximately 1 hour ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): 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|