Accuracy of Pulse Oximeters With Profound Hypoxia at Rest

Study Overview
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Brief Summary
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The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Detailed Description
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This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Official Title
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Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol

Conditions
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Hypoxia

Intervention / Treatment
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* Device: Pulse oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female subjects who can give written informed consent Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile Meeting the demographic requirements Exclusion Criteria: Age below 18 or over 50 Pregnant women Significant arrhythmia Blood pressure above 150 systolic or 90 diastolic Carboxyhemoglobin levels over 3% Subjects whom the investigator consider ineligible 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult healthy subjects<br>Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state | Device: Pulse oximeter<br>* OLV-4202 pulse oximeter (SW version: 01-11)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor Oxygen Saturation by Arms Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n) | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor Pulse Rate by Arms Calculation | Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n) | 30 seconds |