Dysfunctional Hemoglobin

Study Overview
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Brief Summary
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The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.

Official Title
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Dysfunctional Hemoglobin Pulse Co-ox

Conditions
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Elevated Levels of Carboxyhemoglobin and Methemoglobin

Intervention / Treatment
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* Other: Elevated levels of carboxyhemoglobin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carboxyhemoglobin<br>Induced carboxyhemoglobin levels up tp 15 percent. | Other: Elevated levels of carboxyhemoglobin<br>* Comparison of pulse co-oximeters<br>* Other names: Elevated levels of methemoglobin;|
| Methemoglobin<br>Induced methemoglobin levels up to 15 percent. | Other: Elevated levels of carboxyhemoglobin<br>* Comparison of pulse co-oximeters<br>* Other names: Elevated levels of methemoglobin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin |  | 4 hours | 
| Determine oxygen saturation accuracy in conditions of elevated methemoglobin |  | 4 hours |