Comparison of Normal Readings and Repeatability Across Skin Colors

Near Infrared Spectroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326819
• Other study ID #: QATP1962
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: May 9, 2013
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2012
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Near Infrared Spectroscopy

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No