Butterfly Sensor With Rev K Version

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

The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.

Study Overview

• Status: Terminated
• Conditions: Blood Loss

Detailed Description

• Masimo SpHb™ continuous hemoglobin monitoring The Masimo SpHb™ monitor with the Butterfly Sensor with RevK version will be used to continuously monitor hemoglobin electronically. The Butterfly Sensor will be connected to the 3rd or 4th finger on either the right or left hand.
• Masimo Pronto-7™ intermittent hemoglobin monitoring The Masimo Pronto-7™ is a hand-held, noninvasive device used for intermittent measuring of blood hemoglobin. The device is connected to a re-usable sensor which is clipped onto a finger for quick spot-check readings. A reading from the Pronto-7 will be taken immediately before surgery.
• Blood sampling for hemoglobin determination For the study, about a ½ tsp of blood will be collected from the arterial line placed for the purpose of surgery approximately every hour during the surgery to obtain a hemoglobin measurement to be analyzed in the UCSF Clinical Lab.

• Study Type: Observational
• Enrollment (Actual): 9

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 and older (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 of non-pregnant female 18 y/o or older
• American Society of Anesthesiologists Classification 1,2 or 3
• Scheduled to undergo spine or hip surgery

Exclusion Criteria:

• Pregnant or nursing
• Patients who in the 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
Patients undergoing spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level.	During surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 10-00524F