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Invasive induced hypoxia study to evaluate the accuracy of oxygen saturation(SpO2) of pulse oximeter(CART-I, SkyLabs Inc) in adult healthy volunteers

Not Applicable
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
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/d

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
-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
NameTimeMethod
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
NameTimeMethod
safety
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