A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers
- Conditions
- Oxygen Saturation
- Registration Number
- NCT05895682
- Lead Sponsor
- Seers Technology Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Accuracy of SpO2 2 day 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seers Technology Co., Ltd.
🇰🇷Pyeongtaek-si, Gyeonggi-do, Korea, Republic of
Seers Technology Co., Ltd.🇰🇷Pyeongtaek-si, Gyeonggi-do, Korea, Republic of