Accuracy of Pulse Oximeters With Profound Hypoxia at Rest

Completed

• Conditions: Hypoxia
• Interventions: Device: Pulse oximeter

• Registration Number: NCT04814823
• Lead Sponsor: Nihon Kohden

Brief 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 at rest.

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 at rest.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study Start: 2021-03-24
• Study First Posted: 2021-03-24
• Primary Completion: 2021-05-24
• Study Completion: 2022-02-15
• Results First Submitted: 2022-04-13
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Results First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult healthy subjects	Pulse oximeter	Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state

Primary Outcome Measures

Name	Time	Method
Accuracy of Sensor Oxygen Saturation by Arms Calculation	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 Outcome Measures

Name	Time	Method
Accuracy of Sensor Pulse Rate by Arms Calculation	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)

Trial Locations

Locations (1)

UCSF Hypoxia Research Laboratory; 🇺🇸 San Francisco, California, United States