Invasive induced hypoxia study to evaluate the accuracy of oxygen saturation(SpO2) of pulse oximeter(CART-I, SkyLabs Inc) in adult healthy volunteers
- Conditions
- Not Applicable
- Registration Number
- KCT0005888
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- 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/d
-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
-Those who are judged to be difficult to collect normal signals because CART-I is loose when wearing CART-I on fingers other than thumb and hand.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 safety