Fingertip Pulse Oximeter Clinical Test

This study has been completed.
Information provided by (Responsible Party):
Andon Health Co., Ltd Identifier:
First received: May 23, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
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


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


Ages Eligible for Study:   25 Years to 32 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Andon Health Co., Ltd Identifier: NCT01605955     History of Changes
Other Study ID Numbers: AndonHealth8
Study First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Andon Health Co., Ltd:
SPO2 processed this record on November 25, 2015