Fingertip Pulse Oximeter Clinical Test

NCT01605955 | Completed

• 1 other identifier: AndonHealth8
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Conditions

SPO2

Keywords

SPO2

Study Arms (2)

Fingertip Pulse Oximeter

SPO2 measurement range: 70%-99%

CO-oximeter

SaO2 measurement range: 70%-99%

Eligibility Criteria

• Age: 25 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers who consent to induced hypoxia and arterial blood sampling as part of the experimental procedure

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andon Health Co., Ltd: lead

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 25, 2012

Record last verified: 2012-04