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A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers

NCT05895682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-06-08

No results posted yet for this study

Summary

It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in clinical practice. The US FDA only allows the use of devices that meet the ISO 80601-2-61:2017 standard in the United States. According to the ISO 80601-2-61:2017 standard, the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range of 70-100%. To prove compliance with this requirement, it is necessary to conduct a clinical trial that induces hypoxemia in healthy adults and compares and evaluates the arterial blood oxygen saturation values of the pulse oximeter's SpO2 and the arterial blood oxygen saturation values of the carbon monoxide-oxygen meter (CO-oximeter).

Conditions

  • Oxygen Saturation

Interventions

DEVICE

mobiCARE +Pulse (MP100W)

Volunteers were monitored using end-tidal carbon dioxide partial pressure and fraction of inspired oxygen. Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the nitrogen-air-carbon dioxide mixtures. A nose clip was applied to prevent breathing of room air. For frequent blood sampling, an arterial cannula was placed in the radial artery of each volunteer. Pulse oximeter probes were simultaneously attached to each volunteer's fingers. Each volunteer was exposed to various levels of induced hypoxia from 70\~100% of SaO2. Each plateau of oxygen saturation was maintained for at least 30 s until stabilization, after which 1 ml of arterial blood was drawn into a heparinized syringe. The study period consisted of two rounds of hypoxia, and the volunteers were maintained on room air between each round. SaO2 measurements using a CO-oximeter were used as a reference for the SpO2 accuracy.

Sponsors & Collaborators

  • Seers Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-29
Primary Completion
2023-05-14
Completion
2023-05-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05895682 on ClinicalTrials.gov