Dysfunctional Hemoglobin Pulse Oximetry

Completed

Conditions studied: Carbon Monoxide Poisoning

In brief

The purpose of the study is to assess device performance in the presence of carbon monoxide.

Key facts

Study ID

NCT03030833

Run by

Nonin Medical, Inc

People needed

36

Starts

2017-02-06

Expected to finish

2017-04-30

Last updated by the study team

2017-09-01

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not 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 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.

Where it is running

• HPPL Duke Univeristy — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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