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Comparison of Normal Readings and Repeatability Across Skin Colors

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ClinicalTrials.gov Identifier: NCT01326819
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc

Brief Summary:
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.

Condition or disease
Near Infrared Spectroscopy

Study Type : Observational
Actual Enrollment : 231 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy




Primary Outcome Measures :
  1. The mean and standard deviation of readings with all four regional oxygen saturation devices. [ Time Frame: Data analysis will be performed when 240 subjects have been enrolled (7 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Male or Female
  • of any race or ethnicity
  • greater than eighteen years of age
  • weighs greater than or equal to 40 kilograms
  • is not currently admitted to the hospital
  • is not known to be pregnant
  • understands English
  • is willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

  • is less than eighteen years of age
  • weighs less than 40 kilograms
  • if known to be pregnant
  • is a current patient in the hospital
  • does not understand English
  • has known anemia
  • is unwilling and able to provide informed consent and comply with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326819


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
Principal Investigator: Kumar Belani, MD Univeristy of Minnesota

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01326819     History of Changes
Other Study ID Numbers: QATP1962
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: November 2012

Keywords provided by Nonin Medical, Inc:
Near infrared spectroscopy
Skin pigmentation
Regional oxygen saturation