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Completed

NCT Number: NCT05745662

Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO17)

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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Hypoxia Research Laboratory

San Francisco, California, 94133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Oximeter

Device

OLV-4202 pulse oximeter (SW version: 01-15)

Primary outcomes

  1. Accuracy of Sensor Oxygen Saturation by Arms Calculation

    Time frame: 30 seconds

    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)

Secondary outcomes

  1. Accuracy of Sensor Pulse Rate by Arms Calculation

    Time frame: 30 seconds

    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)

Sponsors and collaborators

Lead sponsor

Nihon Kohden

Industry

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 27, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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