Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19)

Hypoxia Clinical Trial

Official title:

Determination of SpO2 and PR Accuracy Specifications at Rest / Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 19/ Pulse Oximeter Accuracy Evaluation Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807477
• Other study ID #: 72Ag_Vital-00014
• Status: Recruiting
• Start date: April 18, 2023
• Est. completion date: April 16, 2025

Study information

• Verified date: April 2023
• Source: Nihon Kohden
• Contact: Philip Bickler, MD, PhD
• Phone: 1-415-476-1411
• Email: philip.bickler[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: April 16, 2025
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 below

• 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

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• Pulse Oximeter
OLV-4202 pulse oximeter (SW version: 01-15)

Locations

Country	Name	City	State
United States	UCSF Hypoxia Research Laboratory	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Nihon Kohden	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 seconds
Secondary	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)	30 seconds