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

Oxygen Saturation (SpO2) Accuracy Validation of Sky Labs Inc. CART-I, Wearable Device. Single center, observational study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005888

Enrollment

Registered

2021-02-15

Start date

2021-03-20

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(induced hypoxia study) : Each study participant inhales a mixed gas consisting of medical air, nitrogen and carbon dioxide to induce hypoxic state, and maintains the arterial oxygen saturation

. After allowing the arterial oxygen saturation value to reach a plateau for 30 seconds, 1 ml of arterial blood is collected from the arterial conduit, and this process is repeated twice in one volunt

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

Exclusion criteria

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.

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
safety	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Yeon Bang

Asan Medical Center

Outcome results