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CompletedNCT01304550Updated May 30, 2017

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

An observational study in Accuracy of Non-invasive Hemoglobin Monitor, sponsored by University of California, Davis. Completed. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
48
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Accuracy of Non-invasive Hemoglobin Monitor

Keywords

  • non-invasive
  • hemoglobin
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In context

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patience undergoing elect cardiac surgery.

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
48 participants (actual)
06

What researchers measure

Primary outcomes

  1. Accuracy of Masimo Monitor

    365 Days

    Time frame: 1 Year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01304550
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Feb 25, 2011
Start date
Jul 2009
Primary completion
Jul 2010
Completion
Jul 2010
Last update
May 30, 2017

Study contacts

Neal W. Fleming, M.D., Ph.D.
study director · Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Aubrey Yao, M.D.
principal investigator · Faculty, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Gudrun Kungys, M.D.
principal investigator · Faculty, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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