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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
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.

Brief Summary:
Accuracy of the oximeter.

Condition or disease Intervention/treatment
Healthy Volunteers Device: Mespere Oximeter Device: Radiometer OSM-3 Co-Oximeter

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Healthy volunteers
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.



Primary Outcome Measures :
  1. Venous Oxygen Saturation Accuracy Verification against Co-Oximeter [ Time Frame: approximately 1 hour ]

Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01583634


Locations
United States, California
University of California, San Francisco, Induced Hypoxia Lab
San Francisco, California, United States, 94143
Sponsors and Collaborators
Mespere Lifesciences Inc.
Investigators
Principal Investigator: Philip E Bickler, MD, PhD University of California, San Francisco

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01583634     History of Changes
Other Study ID Numbers: MLS STP-9100001
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms