Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Healthy Volunteers Clinical Trial

Official title:

Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583634
• Other study ID #: MLS STP-9100001
• Status: Completed
• Phase: N/A
• First received: April 12, 2012
• Last updated: October 2, 2014
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Mespere Lifesciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Accuracy of the oximeter.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 49 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Mespere Oximeter
Mespere oximeter provides non-invasive venous blood oxygen saturation.
• Radiometer OSM-3 Co-Oximeter
OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.

Locations

Country	Name	City	State
United States	University of California, San Francisco, Induced Hypoxia Lab	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Mespere Lifesciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Oxygen Saturation Accuracy Verification against Co-Oximeter		approximately 1 hour	No