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Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol

NCT04814342•Nihon Kohden

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

March 24, 2021

Primary Completion Date

May 24, 2021

Completion Date

February 15, 2022

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Hypoxia

Interventions

Pulse oximeter

DEVICE

The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery

NCT07326293

DesaturationApnea, Hypoxia+1 more

View study

RECRUITINGNA

Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

NCT06966934

HypoxiaObesity+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

Inclusion Criteria

Exclusion Criteria

The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery

Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

Added Diagnostic Value of Point of Care Ultrasound in Acute Dyspnea

Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia

High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill

Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events