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Fingertip Pulse Oximeter Clinical Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01605955
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Information provided by (Responsible Party):
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

Condition or disease

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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Study Start Date : November 2011
Actual Study Completion Date : December 2011

Fingertip Pulse Oximeter
SPO2 measurement range: 70%-99%
SaO2 measurement range: 70%-99%

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers who consent to induced hypoxia and arterial blood sampling as part of the experimental procedure

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.

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Responsible Party: Andon Health Co., Ltd Identifier: NCT01605955    
Other Study ID Numbers: AndonHealth8
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: April 2012
Keywords provided by Andon Health Co., Ltd: