Carbon Monoxide Poisoning
Conditions
Brief summary
The purpose of the study is to assess device performance in the presence of carbon monoxide.
Interventions
DEVICEPulse Oximeter
Comparison of pulse oximetry to blood gas analyzer.
Sponsors
Nonin Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carboxyhemoglobin accuracy | Through study completion, an average of 3 months. | Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device. |
Countries
United States
Outcome results
None listed