Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
1 other identifier
observational
9
1 country
1
Brief Summary
Accuracy of the oximeter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 3, 2014
October 1, 2014
Same day
April 12, 2012
October 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter
approximately 1 hour
Study Arms (1)
Healthy volunteers
9 subjects (male and female)
Interventions
Mespere oximeter provides non-invasive venous blood oxygen saturation.
OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.
Eligibility Criteria
Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones
You may qualify if:
- Healthy volunteers between the ages of 21 and 49 years of either gender
You may not qualify if:
- smokers
- pregnancy
- any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease
- obesity
- evidence of abnormal neck vein anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco, Induced Hypoxia Lab
San Francisco, California, 94143, United States
Biospecimen
Whole blood
Study Officials
- PRINCIPAL INVESTIGATOR
Philip E Bickler, MD, PhD
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 24, 2012
Study Start
September 1, 2014
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
October 3, 2014
Record last verified: 2014-10