- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01184521
Masimo CO-Oximeter Study
January 27, 2012 updated by: Joseph D. Tobias, Nationwide Children's Hospital
Use of the Masimo Rainbow SET Pulse CO-Oximeter in Patients Undergoing Isovolemic Hemodilution
This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
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
-
-
Ohio
-
Columbus, Ohio, United States, 43147
- Nationwide Children's Hospital
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients requiring isovolemic hemodilution during surgery.
Description
Inclusion Criteria:
- Any subject that is scheduled to have isovolemic hemodilution
Exclusion Criteria:
- Anything that prevents a subject from having isovolemic hemodilution
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
Cohorts and Interventions
Group / Cohort |
---|
pulse CO-oximeter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemoglobin value
Time Frame: 1 Day (day of surgery)
|
The accuracy of the hemoglobin value from the Masimo pulse oximeter during isovolemic hemodilution.
|
1 Day (day of surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 17, 2010
First Submitted That Met QC Criteria
August 18, 2010
First Posted (Estimate)
August 19, 2010
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 27, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- IRB10-00364
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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