Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

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.

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Key information

Conditions

Surgery Hemoglobin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Health

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients scheduled for elective surgery requiring intra-arterial pressure monitoring

Exclusion criteria

Age less than 18 years
Pregnancy
Prisoners

Treatment and study plan

Pulse CO-Oximetry Technology

Device

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.

Blood Draw

Other

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.

Primary outcomes

Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery

Time frame: Five year

Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2024
Study completion: 2024
First posted: Nov 28, 2013
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed