Dysfunctional Hemoglobin Pulse Oximetry
Status: | Completed |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 9/2/2017 |
Start Date: | February 6, 2017 |
End Date: | April 30, 2017 |
Dysfunctional Hemoglobin Pulse Oximeter
The purpose of the study is to assess device performance in the presence of carbon monoxide.
Inclusion Criteria:
- The subject is male or female.
- The subject is of any racial or ethnic group.
- The subject is between 18 years and 50 years of age (self-reported).
- The subject does not have significant medical problems (self-reported).
- The subject is willing to provide written informed consent and is willing and able to
comply with study procedures.
- Exclusion Criteria:
- Has a BMI greater than 30.0 (calculated from self-reported weight and height).
- Has had any relevant injury at the sensor location site (self-reported).
- Has a deformity or abnormalities that may prevent proper application of the device
under test (based on visual inspection).
- Has a known respiratory condition (self-reported).
- Is currently a smoker (self-reported).
- Has a known heart or cardiovascular condition (self-reported).
- Is currently pregnant (positive serum pregnancy test at screening visit or positive
urine POC test on day of study).
- Is female and actively trying to get pregnant (self-reported).
- Has a clotting disorder (self-reported).
- Has Raynaud's Disease (self-reported).
- Is known to have anemia (hemoglobin value below lower range of normal for gender)
- Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia
(abnormal hemoglobin electrophoresis).
- Is known to have a inherited or congenital methemoglobinemia (self-reported).
- Has unacceptable collateral circulation from the ulnar artery (based on exam).
- Is unwilling or unable to provide written informed consent to participate in the
study.
- Has another health condition which in the opinion of the principal investigator makes
him/her unsuitable for testing.
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