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NCT01997502 Clinical Trial

Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01997502
Other study ID # 494171
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 26, 2013
Est. completion date January 1, 2025

Study information
Verified date August 2023
Source University of California, Davis
Contact Neal W Fleming, M.D., Ph.D.
Phone 916-734-5394
Email nwfleming@ucdavis.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients scheduled for elective surgery requiring intra-arterial pressure monitoring Exclusion Criteria: - Age less than 18 years - Pregnancy - Prisoners

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Pulse CO-Oximetry Technology
In addition to the standard pulse oximeter used for clinical care, up to six SpHb finger sensors will be applied to the patient. Additional sensors may also be applied to the forehead, neck, chest and ears. Masimo FDA cleared pulse CO-Oximeter devices: Radical-7, Rad-87, Rad-57, Pronto, Pronto-7, for the noninvasive measurement of SpO2, PR, PI, PVI, SpCO, SpMet, and SpHb, total hemoglobin and respiratory rate. No treatment decisions will be made based on the new technology and no extra medical procedures are required for the study.
Other:
• Blood draw
4mL arterial blood samples (up to 1 per hour), outside standard of care, are drawn throughout the surgical procedure and sent to UCDMC lab/Masimo lab for analysis.

Locations
Country Name City State
United States UC Davis Health Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb. Five year
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