Fingertip Pulse Oximeter Clinical Test

Completed

• Conditions: SPO2

• Registration Number: NCT01605955
• Lead Sponsor: Andon Health Co., Ltd

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-04
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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;
• Inclusion criteria should serve the purpose of the study

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified