- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01326819
Comparison of Normal Readings and Repeatability Across Skin Colors
May 9, 2013 updated by: Nonin Medical, Inc
Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
231
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 analysis will be performed when 240 subjects have been enrolled (7 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kumar Belani, MD, Univeristy of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 3, 2011
First Submitted That Met QC Criteria
March 30, 2011
First Posted (Estimate)
March 31, 2011
Study Record Updates
Last Update Posted (Estimate)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 9, 2013
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- QATP1962
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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