Elevated Levels of Carboxyhemoglobin and Methemoglobin
Conditions
Brief summary
The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.
Interventions
OTHERElevated levels of carboxyhemoglobin
Comparison of pulse co-oximeters
Sponsors
University of California, San Francisco
Nonin Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects does not have significant medical problems * Subject is willing to provide written informed consent * Subject is between 18 and 45 years of age
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 * 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 * Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry | 4 hours |
| Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin | 4 hours |
| Determine oxygen saturation accuracy in conditions of elevated methemoglobin | 4 hours |
Countries
United States
Outcome results
None listed