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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01304550
Enrollment
48
Registered
2011-02-25
Start date
2009-07-31
Completion date
2010-07-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accuracy of Non-invasive Hemoglobin Monitor

Keywords

non-invasive, hemoglobin

Brief summary

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

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.

Interventions

None listed

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Masimo Monitor1 Year365 Days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026