Accuracy of Continuous SpO2 Measurement in Adults

Status:

WITHDRAWN

Accuracy of Continuous SpO2 Measurement in Adults

Lead Sponsor:

Sotera Wireless, Inc.

Conditions:

Healthy

Eligibility:

All Genders

18+ years

Brief Summary

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.

Detailed Description

This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background. SpO2 and pulse rate measurements reported by ViSi will be compared with...

Eligibility Criteria

Inclusion

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.

Exclusion

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.

Key Trial Info

Start Date :

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT01183338

Last Update

June 22 2011

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