Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

NCT ID: NCT01583634

Last Updated: 2014-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-10-31

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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

9 subjects (male and female)

Mespere Oximeter

Intervention Type: DEVICE

Mespere oximeter provides non-invasive venous blood oxygen saturation.

Radiometer OSM-3 Co-Oximeter

Intervention Type: DEVICE

OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.

Interventions

Mespere Oximeter

Mespere oximeter provides non-invasive venous blood oxygen saturation.

Intervention Type: DEVICE

Radiometer OSM-3 Co-Oximeter

OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mespere Lifesciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip E Bickler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco, Induced Hypoxia Lab

San Francisco, California, United States

Countries

United States

Other Identifiers

MLS STP-9100001

Identifier Type: -

Identifier Source: org_study_id