Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: Mespere Oximeter; Device: Radiometer OSM-3 Co-Oximeter

• Registration Number: NCT01583634
• Lead Sponsor: Mespere Lifesciences Inc.

Brief Summary

Accuracy of the 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 Timeline

• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Study Start: 2014-09
• Primary Completion: 2014-09
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Radiometer OSM-3 Co-Oximeter	9 subjects (male and female)
Healthy volunteers	Mespere Oximeter	9 subjects (male and female)

Primary Outcome Measures

Name	Time	Method
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter	approximately 1 hour

Trial Locations

Locations (1)

University of California, San Francisco, Induced Hypoxia Lab; 🇺🇸 San Francisco, California, United States