Comparison of Normal Readings and Repeatability Across Skin Colors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT01326819
First received: March 3, 2011
Last updated: May 9, 2013
Last verified: November 2012
  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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01326819     History of Changes
Other Study ID Numbers: QATP1962
Study First Received: March 3, 2011
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014