Accuracy of Continuous SpO2 Measurement in Adults

Withdrawn before enrolling

Conditions studied: Healthy

In brief

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

Key facts

Study ID

NCT01183338

Run by

Sotera Wireless, Inc.

People needed

15

Last updated by the study team

2011-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is at least 18 years of age.
• Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
• Subject is willing and able to participate in the measurement period for up to two hours.

You may not qualify if…

• Subject has a carboxyhemoglobin level (COHb) ≥3%.
• Subject has a MetHb level ≥2%.
• Subject has a ctHb value ≤10g/dl.
• Subject is in another clinical study that may interfere with the results of this study.
• Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
• Subject is deemed by the Investigator to be medically unsuitable for participation in this study.

Where it is running

• Clinimark Desaturation Laboratory — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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