SpO2 System Accuracy Testing With Different Sensors

Study Overview
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Brief Summary
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A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.

Detailed Description
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The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.

Official Title
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SpO2 System Accuracy Testing

Conditions
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Pulse Oximetry

Intervention / Treatment
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* Device: Pulse oximetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent or have a legally authorized representative provide written informed consent Subjects who are 18-55 years of age Subjects must be willing and able to comply with study procedures HbCO<3% (for smokers only) Exclusion Criteria: Subject or a legally authorized representative is unable to provide written inform consent. Subjects that are considered morbidly obese (defined as BMI > 39.5), Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test, Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow). Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease), Subjects with known heart or cardiovascular conditions, Female subjects that are actively trying to get pregnant or are pregnant, Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study), Subjects with Systolic blood pressure >140mmHg, Subjects with Diastolic blood pressure >100mmHg, Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Pulse oximetry monitoring<br>The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference. | Device: Pulse oximetry<br>* Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy Root Mean Square (ARMS) | The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007). | 60 minutes |