Dysfunctional Hemoglobin CO-ox
Completed
Conditions studied: Elevated Levels of Carboxyhemoglobin
In brief
The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.
Key facts
- Study ID
- NCT02427685
- Run by
- Nonin Medical, Inc
- People needed
- 27
- Starts
- 2015-04-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2015-06-17
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- The subject is male or female.
- The subject is of any racial or ethnic group.
- The subject is between 18 years and 45 years of age.
- The subject does not have significant medical problems.
- The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
You may not qualify if…
- Has a BMI greater than 31
- Has had any relevant injury at the sensor location site
- Has deformities or abnormalities that may prevent proper application of the device under test.
- Has a known respiratory condition.
- Is currently a smoker.
- Has a known heart or cardiovascular condition.
- Is currently pregnant.
- Is female and actively trying to get pregnant.
- Has a clotting disorder.
- Has Raynaud's Disease.
- Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia).
- The subject has a COHb greater than 3% or MetHb greater than 2%.
- Has taken blood thinners or medication with aspirin within the last 24 hours.
- Has unacceptable collateral circulation from the ulnar artery.
- Has donated more than 300 mL of blood within one month prior to start of study.
- Is unwilling or unable to provide written informed consent to participate in the study.
- Is unwilling or unable to comply with the study procedures for the primary objectives.
- Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Where it is running
- University of California San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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