Comparison of Normal Readings and Repeatability Across Skin Colors

Nonin Medical, Inc231 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

231

Conditions

Near Infrared Spectroscopy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

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)

Data from ClinicalTrials.gov

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