Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Accuracy of Non-invasive Hemoglobin Monitor Clinical Trial

Official title:

Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304550
• Other study ID #: 200917394
• Secondary ID: 200917394-1
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: May 24, 2017
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas analysis and the Masimo Continuous Hemoglobin Monitor

Description:

The chief objective of this study is to internally validate the accuracy of the Masimo SpHb (TM) technology as compared to our laboratory measurement of Hb. We have been using the Masimo SpHb monitor on patients who underwent open heart surgery, hepatic resection, kidney transplant and aortic aneurysm repair since January 2009. These patients also had hemoglobin concentration measurements as part of the arterial blood gas analysis performed by our laboratory to evaluate intraoperative ventilation and electrolyte changes. We will collate the laboratory measurements with the Masimo SpHb values documented in the anesthetic records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who had indwelling arterial catheters placed for surgeries that involved major blood loss and who had serial hemoglobin concentration measurements for their surgeries, since January 2009. This will represent approximately 50 patients.

Exclusion Criteria:

• Inclusion criteria are patients undergoing major surgery from January 2009 - April 2009, who had continuous hemoglobin pulse oximetry readings form the Masimo SpHb monitor and serial hemoglobin concentration measurement from the lab. Patient who did not have these studies will be excluded.

Related Conditions & MeSH terms

• Accuracy of Non-invasive Hemoglobin Monitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Masimo Monitor	365 Days	1 Year