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Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01997502
Recruitment Status : Recruiting
First Posted : November 28, 2013
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment
Surgery Hemoglobin Device: Pulse CO-Oximetry Technology Other: Blood draw

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases
Actual Study Start Date : November 26, 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective surgery.

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01997502

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Contact: Neal W Fleming, M.D., Ph.D. 916-734-5394
Contact: Ana Arias, BS 916-703-5456

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United States, California
UC Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Neal W Fleming, M.D., Ph.D.    916-734-5394   
Contact: Ana Arias, BS    916-703-5456   
Principal Investigator: Neal W Fleming, MD, PhD         
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Neal Fleming, M.D., Ph.D. Professor, Director, Cardiovascular and Thoracic Anesthesiology
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Responsible Party: University of California, Davis Identifier: NCT01997502    
Other Study ID Numbers: 494171
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of California, Davis: