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Fingertip Pulse Oximeter Clinical Test

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605955
First Posted: May 25, 2012
Last Update Posted: May 25, 2012
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.
Information provided by (Responsible Party):
Andon Health Co., Ltd
  Purpose
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
SPO2

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Andon Health Co., Ltd:

Enrollment: 10
Study Start Date: November 2011
Study Completion Date: December 2011
Groups/Cohorts
Fingertip Pulse Oximeter
SPO2 measurement range: 70%-99%
CO-oximeter
SaO2 measurement range: 70%-99%

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Andon Health Co., Ltd
ClinicalTrials.gov Identifier: NCT01605955     History of Changes
Other Study ID Numbers: AndonHealth8
First Submitted: May 23, 2012
First Posted: May 25, 2012
Last Update Posted: May 25, 2012
Last Verified: April 2012

Keywords provided by Andon Health Co., Ltd:
SPO2