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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
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.

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 November 20, 2014