Determination of SpO2 and PR Accuracy Specifications 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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Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 14

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: 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: 01-12)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%) | Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value. | 30 minutes | 
| Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min]) | Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% Pulse rate is recorded from the test device and from the reference ECG monitor. PR data measurements are gathered during the stable plateau value at the desired saturation target. Each desaturation plateaus should not exceed 10 minutes. The gas mixture is then changed for the next value and repeated for each plateau value. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at desaturation levels (80% to 100%) and within +-3% [%SpO2] at desaturation levels (70% to 80%) | Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value. | 30 minutes |