Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01605955
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Andon Health Co., Ltd

Tracking Information
First Submitted Date May 23, 2012
First Posted Date May 25, 2012
Last Update Posted Date May 25, 2012
Study Start Date November 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fingertip Pulse Oximeter Clinical Test
Official Title Not Provided
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 Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population healthy volunteers who consent to induced hypoxia and arterial blood sampling as part of the experimental procedure
Condition SPO2
Intervention Not Provided
Study Groups/Cohorts
  • Fingertip Pulse Oximeter
    SPO2 measurement range: 70%-99%
  • CO-oximeter
    SaO2 measurement range: 70%-99%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2012)
10
Original Actual Enrollment Same as current
Actual Study Completion Date December 2011
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 32 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01605955
Other Study ID Numbers AndonHealth8
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andon Health Co., Ltd
Study Sponsor Andon Health Co., Ltd
Collaborators Not Provided
Investigators Not Provided
PRS Account Andon Health Co., Ltd
Verification Date April 2012