Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Accuracy of the oximeter.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: 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
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco, Induced Hypoxia Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter	approximately 1 hour

Collaborators and Investigators

• Sponsor: Mespere Lifesciences Inc.
• Investigators: Principal Investigator: Philip E Bickler, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 20, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): October 3, 2014
• Last Update Submitted That Met QC Criteria: October 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: MLS STP-9100001