NCT01583634

Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Mespere Lifesciences Inc. · Industry
• Sex: All
• Age: 21 Years – 49 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2012-04-24
• Last updated: 2014-10-03

Locations

1 site across 1 country: United States