A Clinical study to re-validate the accuracy of the Sky Labs pulse oximeter (CART O2) in healthy Korean adult volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012381

Enrollment

Registered

2026-08-02

Start date

2026-08-29

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

None listed

Interventions

Others(Accuracy evaluation of pulse oximeter) : Volunteers were monitored using end-tidal carbon dioxide partial pressure and fraction of inspired oxygen by using Carescape® B850 (GE Healthcare, Milwa

Radiometer Medical A/S, Copenhagen, Denmark) were used as a reference for the SpO2 accuracy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Healthy adults between 20 and 50 years -Carboxyhemoglobin (COHb) 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 - History of allergic reaction to lidocaine, a local anesthetic

Design outcomes

Primary

Measure	Time frame
The root mean square (Arms) of the difference between the SpO2 measured by the test device and the SaO2 measured by CO-oximetry, over an arterial oxygen saturation range of 70–100%.	—

Secondary

Measure	Time frame
Occurrence of dizziness or nausea as symptoms of hypoxia	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-1704

Outcome results