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OpenTrials
Completed

NCT Number: NCT01583634

Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Accuracy of the oximeter.

Completed

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Key information

Conditions

Age range

21 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, Induced Hypoxia Lab

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mespere Oximeter

Device

Mespere oximeter provides non-invasive venous blood oxygen saturation.

Radiometer OSM-3 Co-Oximeter

Device

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

Primary outcomes

  1. Venous Oxygen Saturation Accuracy Verification against Co-Oximeter

    Time frame: approximately 1 hour

Sponsors and collaborators

Lead sponsor

Mespere Lifesciences Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2012
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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