Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01997502

Enrollment

621

Registered

2013-11-28

Start date

2013-11-26

Completion date

2024-10-21

Last updated

2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoglobin, Surgery

Keywords

Hemoglobin, Non-invasive

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.

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.

Interventions

DEVICEPulse 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.

OTHERBlood 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Age less than 18 years * Pregnancy * Prisoners

Design outcomes

Primary

Measure	Time frame	Description
Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery	Five year	Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026