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:

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

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

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 May 22, 2013