Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

Study Overview
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Brief Summary
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In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Conditions
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Healthy

Intervention / Treatment
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* Device: Rainbow Universal Pulse Oximeter Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The subject is male or female, aged ≥18 and <50. The subject is in good general health with no evidence of any medical problems. The subject is fluent in both written and spoken English. The subject has provided informed consent and is willing to comply with the study procedures. Exclusion Criteria: The subject is obese (BMI>30). The subject has a known history of heart disease, lung disease, kidney or liver disease. Diagnosis of asthma, sleep apnea, or use of CPAP. Subject has diabetes. Subject has a clotting disorder. The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. The subject has any other serious systemic illness. The subject is a current smoker. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. The subject has a history of fainting or vasovagal response. The subject has a history of sensitivity to local anesthesia or allergy to the study drugs. The subject has a diagnosis of Raynaud's disease. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). The subject is pregnant, lactating or trying to get pregnant. The subject has a history of migraine headaches. The subject is currently taking antidepressants. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rainbow Universal Pulse Oximeter Sensor<br>All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor. | Device: Rainbow Universal Pulse Oximeter Sensor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor by Arms Calculation | Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. | 5 hours |