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NCT01184521 Clinical Trial

Masimo CO-Oximeter Study

Cardiac Surgical Procedures Clinical Trial

Official title:
Use of the Masimo Rainbow SET Pulse CO-Oximeter in Patients Undergoing Isovolemic Hemodilution

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01184521
Other study ID # IRB10-00364
Secondary ID
Status Completed
Phase Phase 0
First received August 17, 2010
Last updated January 27, 2012
Start date September 2010
Est. completion date July 2011

Study information
Verified date January 2012
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Any subject that is scheduled to have isovolemic hemodilution

Exclusion Criteria:

- Anything that prevents a subject from having isovolemic hemodilution

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary hemoglobin value The accuracy of the hemoglobin value from the Masimo pulse oximeter during isovolemic hemodilution. 1 Day (day of surgery) Yes
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