Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:6/14/2018
Start Date:November 26, 2013
End Date:December 2020
Contact:Neal W Fleming, M.D., Ph.D.
Email:nwfleming@ucdavis.edu
Phone:916-734-5394

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Trial Summary
Trial Overview
Inclusion Criteria

Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases

This protocol is a request from Masimo to assist in the collection of data to be used to
further refine the accuracy of the monitor's algorithm.

The specific aim of this study is to collect data to characterize Masimo's noninvasive
Rainbow SpHb technology during surgeries. The purpose is to compare Masimo Rainbow technology
to arterial blood samples taken during surgery. Hemoglobin concentrations in the arterial
blood samples will be measured using standard blood analyzers on site and/or the sponsor's
laboratory.

Inclusion Criteria:

- Patients scheduled for elective surgery requiring intra-arterial pressure monitoring

Exclusion Criteria:

- Age less than 18 years

- Pregnancy

- Prisoners
We found this trial at
1
site
UC Davis Health
2315 Stockton Blvd
Sacramento, California 95817
Principal Investigator: Neal W Fleming, MD, PhD
Phone: 916-734-5394
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mi
from
Sacramento, CA
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