Accuracy of Continuous SpO2 Measurement in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

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Detailed Description

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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 simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Conditions

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Healthy

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes