Comparison of Normal Readings and Repeatability Across Skin Colors

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

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Key information

Conditions

Near Infrared Spectroscopy Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Registry information

Official study title

Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 31, 2011
Registry last updated: May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed