Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

NCT01997502 | Completed FDA Device

• 1 other identifier: 494171
• Study Type: observational
• Target: 621
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Hemoglobin

Keywords

Hemoglobin; Non-invasive

Outcome Measures

Primary Outcomes (1)

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

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

  Five year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery.

You may qualify if:

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

You may not qualify if:

• Age less than 18 years
• Pregnancy
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Neal Fleming, M.D., Ph.D.

  Professor, Director, Cardiovascular and Thoracic Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 28, 2013
• Study Start: November 26, 2013
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: April 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)