Assessing the Accuracy of the RevK Sensor

Assessing the Accuracy of the RevK Sensor for Non-Invasive Hemoglobin Monitoring

Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Spine Surgery

Detailed Description

Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing spine surgery

Description

Inclusion Criteria:

• Male or non-pregnant female
• American Society of Anesthesiology Classification 1, 2 or 3
• Scheduled to undergo spine or hip surgery

Exclusion Criteria:

• Pregnant or nursing
• Patients who in the study investigators clinical judgement would not be suitable for research

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient undergoing spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value.	Primary outcome is based on the difference between a value from the SpHb (Masimo SpHb™ continuous hemoglobin reading) minus tHb (laboratory hemoglobin determination).	Intermittently during spine surgery

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Ronald D Miller, MD, MS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 10-00524E