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Comparison of Normal Readings and Repeatability Across Skin Colors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326819
First Posted: March 31, 2011
Last Update Posted: May 13, 2013
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):
Nonin Medical, Inc
  Purpose
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.

Condition
Near Infrared Spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors

Resource links provided by NLM:


Further study details as provided by Nonin Medical, Inc:

Primary Outcome Measures:
  • 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) ]

Enrollment: 231
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01326819     History of Changes
Other Study ID Numbers: QATP1962
First Submitted: March 3, 2011
First Posted: March 31, 2011
Last Update Posted: May 13, 2013
Last Verified: November 2012

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