Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01583634
First received: April 12, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

This pilot study is designed to calibrate and validate the Mespere VA Oximeter against a CO-Oximeter on healthy volunteers.


Condition Intervention
Healthy Volunteers
Device: Mespere VA Oximeter
Device: Radiometer OSM-3 Co-Oximeter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

Further study details as provided by Mespere Lifesciences Inc.:

Primary Outcome Measures:
  • SpO2 Accuracy Verification Study, SpO2 between 70% & 100% [ Time Frame: approximately 1 hour ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 9
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers
5 subjects (male and female)
Device: Mespere VA Oximeter
Mespere VA oximeter provides non-invasive measurement of the oxygenation of the venous and arterial blood simultaneously. In the measurement, the venous adhesive patch is placed on top the right external jugular vein and the pulse oximeter probe is placed on the right index finger. The monitor simultaneously displays the oxygenations and plethysmographic waveforms of venous blood and arterial blood.
Device: Radiometer OSM-3 Co-Oximeter
OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin. Using a small sample of 35ul, the Radiometer OSM-3 hemoximeter is capable of measuring 6 parameters such as sO2, ctHb, FO2Hb, FCOHb, FMetHb, and FHHb.

Detailed Description:

Mespere VA (Venous and Arterial) Oximeter is a novel non-invasive medical device for simultaneous monitoring of venous blood oxygenation through the right external jugular vein and arterial blood oxygenation through the finger tip (SpO2).

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 aim of monitoring tissue hypoxia can be achieved by monitoring the balance between oxygen supply (via arterial oxygen saturation) and oxygen demand (via venous oxygen saturation).

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. Furthermore, there is the need for catheter recalibration against a CO-oximeter every 4- 6 hours. 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.

By non-invasively monitoring both venous and arterial blood oxygenation, Mespere VA Oximeter provides more complete information on patient hemodynamics and has clear advantages over conventional pulse oximeters.

  Eligibility

Ages Eligible for Study:   21 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583634

Locations
United States, California
University of California, San Francisco, Induced Hypoxia Lab
San Francisco, California, United States, 94143
Sponsors and Collaborators
Mespere Lifesciences Inc.
Investigators
Principal Investigator: Philip E Bickler, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01583634     History of Changes
Other Study ID Numbers: MLS STP-9000011, MESP01
Study First Received: April 12, 2012
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mespere Lifesciences Inc.:
pulse oximeter
venous oximeter
co-oximeter
healthy volunteers
non-invasive monitor
induced hypoxia
verification of SpO2 accuracy

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014