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

NCT05895682 | Completed

• 1 other identifier: 2022-1657
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

• Accuracy of SpO2

  The root-mean-square of the difference between the observed pulse oximetry value (SpO2) and the carbon monoxide-oxygenometer arterial blood reference value (SRi) within the range of 70-100% of arterial oxygen saturation

  2 day

Study Arms (1)

Induced hypoxia

EXPERIMENTAL

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.

Device: mobiCARE +Pulse (MP100W)

Interventions

mobiCARE +Pulse (MP100W) DEVICE

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.

Induced hypoxia

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adults between 20 and 50 years
• volunteers who have plasma proportion of carboxyhemoglobin 3%
• volunteers who have plasma proportion of methemoglobin 2%
• volunteers who have total plasma hemoglobin concentration over 10 g/dL

You may not qualify if:

• History of respiratory diseases
• History of cardiovascular disease
• Smokers (including ex-smokers)
• Pregnant
• History of fainting
• History of diabetes
• Obesity (BMI\> 30 kg/m2)
• Allen's test results, those who do not recover the color of their fingers and palms within 10 seconds
• History of allergic reaction to lidocaine, a local anesthetic

Sponsors & Collaborators

• Seers Technology Co., Ltd.: lead

Study Sites (1)

Seers Technology Co., Ltd.

Pyeongtaek-si, Gyeonggi-do, 17707, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 8, 2023
• Study Start: April 29, 2023
• Primary Completion: May 14, 2023
• Study Completion: May 15, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)