Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

Nihon Kohden5 enrolled

Overview

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 during controlled motion.

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 during controlled motion.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypoxia

Interventions

Pulse oximeterDEVICE

OLV-4202 pulse oximeter (SW version: 01-11)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Subjects whom the investigator consider ineligible for the study

Locations (1)

UCSF Hypoxia Research Laboratory

San Francisco, California, United States

Outcomes

Primary Outcomes

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)

Time frame: 30 seconds

Secondary Outcomes

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)

Time frame: 30 seconds

Data from ClinicalTrials.gov

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