Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

NCT ID: NCT01997502

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-26

Study Completion Date

2024-10-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgery Hemoglobin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age less than 18 years
* Pregnancy
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Fleming, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, Director, Cardiovascular and Thoracic Anesthesiology

Locations

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UC Davis Health

Sacramento, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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494171

Identifier Type: -

Identifier Source: org_study_id

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