Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb

Completed

• Conditions: Hemoglobin; Surgery

• Registration Number: NCT01997502
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-21
• Study Start: 2013-11-26
• Study First Posted: 2013-11-28
• Primary Completion: 2024-10-21
• Study Completion: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

Inclusion Criteria

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

Exclusion Criteria

• Age less than 18 years
• Pregnancy
• Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UC Davis Health; 🇺🇸 Sacramento, California, United States