Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01583634

Enrollment

Registered

2012-04-24

Start date

2014-09-30

Completion date

2014-10-31

Last updated

2014-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DEVICEMespere Oximeter

Mespere oximeter provides non-invasive venous blood oxygen saturation.

DEVICERadiometer OSM-3 Co-Oximeter

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter	approximately 1 hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026