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Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

NCT01997502 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 621

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Surgery
  • Hemoglobin

Interventions

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.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Neal Fleming, M.D., Ph.D. · Professor, Director, Cardiovascular and Thoracic Anesthesiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-26
Primary Completion
2024-10-21
Completion
2024-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997502 on ClinicalTrials.gov