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

Oxygen Saturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895682
• Other study ID #: 2022-1657
• Status: Completed
• Phase: N/A
• Start date: April 29, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: June 2023
• Source: Seers Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 15, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Oxygen Saturation

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seers Technology Co., Ltd.	Pyeongtaek-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seers Technology Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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