Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

August 11, 2023 updated by: University of California, Davis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health
        • Principal Investigator:
          • Neal W Fleming, MD, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Neal Fleming, M.D., Ph.D., Professor, Director, Cardiovascular and Thoracic Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2013

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimated)

November 28, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 494171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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