A clinical trial to verify the accuracy of MEDIGARD pulse oximeter (WELLCARE100) in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012294

Enrollment

Registered

2026-07-16

Start date

2026-08-08

Completion date

Unknown

Last updated

2026-07-20

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 -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 - History of allergic reaction to lidocaine, a local anesthetic

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
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