Fingertip Pulse Oximeter Clinical Test

NCT ID: NCT01605955

Last Updated: 2012-05-25

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

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in comparison to "gold-standard" measurements of blood SaO2 by a CO-oximeter

Detailed Description

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Conditions

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SPO2

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Fingertip Pulse Oximeter

SPO2 measurement range: 70%-99%

No interventions assigned to this group

CO-oximeter

SaO2 measurement range: 70%-99%

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects participate in the study on a voluntary basis
* All subjects should be in good health at the time of the study. Unless specified otherwise in the protocol, the following values could be applied: COHb\<3 %, MetHb\<2 %, ctHb\>10 g/dl;

Exclusion Criteria

* Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels, unless specific dyshaemoglobins are called for in the study protocol.
* Individuals subject to conditions that result in elevated levels of methaemoglobin, unless specific dyshaemoglobins are called for in the study protocol.
* Subjects who would be placed at undue medical risk associated with any procedures called for in the protocol (e.g. arterial cannulation or hypoxia).
* Age: young person and that of more than 50 years old.
Minimum Eligible Age

25 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Andon Health Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AndonHealth8

Identifier Type: -

Identifier Source: org_study_id

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