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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neal Fleming, MD, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01304550
First received: February 23, 2011
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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


Condition
Accuracy of Non-invasive Hemoglobin Monitor.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Accuracy of Masimo Monitor [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    365 Days


Enrollment: 48
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patience undergoing elect cardiac surgery.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01304550

Sponsors and Collaborators
University of California, Davis
Investigators
Study Director: Neal W. Fleming, M.D., Ph.D. Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Principal Investigator: Aubrey Yao, M.D. Faculty, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Principal Investigator: Gudrun Kungys, M.D. Faculty, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
  More Information

No publications provided

Responsible Party: Neal Fleming, MD, PhD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01304550     History of Changes
Other Study ID Numbers: 200917394, 200917394-1
Study First Received: February 23, 2011
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
non-invasive
hemoglobin

ClinicalTrials.gov processed this record on October 20, 2014