Comparison of Normal Readings and Repeatability Across Skin Colors

NCT ID: NCT01326819

Last Updated: 2013-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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Conditions

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Near Infrared Spectroscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nonin Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kumar Belani, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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QATP1962

Identifier Type: -

Identifier Source: org_study_id

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