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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304550
First Posted: February 25, 2011
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01304550     History of Changes
Other Study ID Numbers: 200917394
200917394-1
First Submitted: February 23, 2011
First Posted: February 25, 2011
Last Update Posted: May 30, 2017
Last Verified: May 2017

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