Comparison of Normal Readings and Repeatability Across Skin Colors

Completed

• Conditions: Near Infrared Spectroscopy

• Registration Number: NCT01326819
• Lead Sponsor: Nonin Medical, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Status Verified: 2012-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean and standard deviation of readings with all four regional oxygen saturation devices.	Data analysis will be performed when 240 subjects have been enrolled (7 months)

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States