An invasive controlled desaturation study to determine SpO2 accuracy of a pulse oximeter (M570T) in healthy adult volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004854

Enrollment

Registered

2020-03-25

Start date

2016-04-20

Completion date

Unknown

Last updated

2020-04-21

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

Conditions

None listed

Interventions

Others(controlled desaturation) : Each volunteer was exposed to various levels of induced hypoxia over 70-100&#37

SaO2. Each plateau of oxygen saturation was maintained for at least 30 s until stabilization, after which 1 ml of arterial blood was drawn into a heparinized syringe. The study period consisted of two

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - aged 20-50 yr - carboxyhemoglobin < 3% - methemoglobin < 2% - total hemoglobin concentration > 10 g/dl

Exclusion criteria

Exclusion criteria: - history of respiratory or cardiovascular disease - smoking habits - evidence of pregnancy - history of syncope - diabetes mellitus - body mass index = 35 kg/m2 - volunteer who is determined to be inappropriate by the researcher

Design outcomes

Primary

Measure	Time frame
a root-mean-square difference of less than or equal to 4.0% SpO2 over the range of 70%–100% SaO2	—

Secondary

Measure	Time frame
safety	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

Outcome results