Comparison of Normal Readings and Repeatability Across Skin Colors

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01326819

Enrollment

231

Registered

2011-03-31

Start date

2011-03-31

Completion date

2012-12-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Near Infrared Spectroscopy

Keywords

Near infrared spectroscopy, Skin pigmentation, Regional oxygen saturation

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Outcome results