Elevated Levels of Carboxyhemoglobin
Conditions
Brief summary
The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.
Interventions
DEVICEPulse Co-Ox
Comparison of pulse co-oximeter to blood gas analyzer.
Sponsors
Nonin Medical, Inc
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry. | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin. | 3 hours |
Countries
United States
Outcome results
None listed