None listed
Conditions
Interventions
Medical Device : In a semi-recumbent position (upper body elevated approximately 30 degrees), the camera integrated into the investigational medical device is adjusted so that the subject’s face align
Sponsors
WONTECH
Eligibility
Sex/Gender
All
Inclusion criteria
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 -Individuals who voluntarily decide to participate in this clinical trial and provide written informed consent. -Individuals who are able to understand and comply with the instructions and participate throughout the entire duration of the clinical trial.
Exclusion criteria
Exclusion criteria: 1) History of respiratory diseases : chronic obstructive pulmonary disease, asthma, or bronchiectasis 2) History of cardiovascular disease : ischemic heart disease, heart failure 3) Smokers : including ex-smokers 4) Pregnant : confirmed by a urine pregnancy test before the clinical trial 5) History of syncope 6) History of diabetes 7) Obesity (BMI> 30 kg/m2) 8) History of allergic reaction to lidocaine, a local anesthetic 9) Other volunteers judged to be inappropriate by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Local bias (difference between expected SpO2 and reference SaO2 values);Mean bias (average difference between SpO2 and SaO2 values);Precision (standard deviation of the difference between SpO2 and SaO2 values) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyung Mi Kim
Asan Medical Center
Outcome results
None listed