Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01583634
First received: April 12, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

This 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:
  • Venous Oxygen Saturation Accuracy Verification against Co-Oximeter [ Time Frame: approximately 1 hour ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 9
Study Start Date: September 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers
9 subjects (male and female)
Device: Mespere VA Oximeter
Mespere VA oximeter provides non-invasive measurement of the oxygenation of the venous blood. In the measurement, the venous adhesive patch is placed on top the right external jugular vein. The monitor displays the oxygenation and plethysmographic waveform of the venous 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 Oximeter is a novel non-invasive medical device for monitoring of venous blood oxygenation through the right external jugular vein.

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 venous blood oxygenation, Mespere VA Oximeter provides more complete information on patient hemodynamics.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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-9100001, MESP05
Study First Received: April 12, 2012
Last Updated: August 14, 2014
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

ClinicalTrials.gov processed this record on October 01, 2014