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

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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.
We found this trial at
1
site
Durham, North Carolina 27710
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mi
from
Durham, NC
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