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

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ClinicalTrials.gov Identifier: NCT00762398
Recruitment Status : Unknown
Verified September 2008 by University of California, Irvine.
Recruitment status was:  Enrolling by invitation
First Posted : September 30, 2008
Last Update Posted : September 30, 2008
Sponsor:
Collaborator:
Masimo Labs
Information provided by:
University of California, Irvine

Brief Summary:
The Masimo monitor can measure hemoglobin level noninvasively and accuratly

Condition or disease Intervention/treatment
Adult Patient Undergoing Major Surgery Device: Masimo hemoglobin-meter Biological: drawing blood sample

Detailed Description:

Blood hemoglobin concentration is a very common and essential test to assess patient well being and the need for blood transfusion. In the perioperative period this measurement is further more critical mainly due to the acute nature of blood loss and the need for an immediate response. Currently, hemoglobin concentration is determined by analyzing a blood sample. It requires venipuncture or arterial puncture (via an arterial line). Besides the patient discomfort there are additional disadvantages such as infection, dealing with blood product, delay with diagnosis, low update rate and cost. Masimo Labs is in the process of developing a noninvasive monitor to detect hemoglobin concentrations in real time. The monitor uses a probe placed on the patient finger that gives hemoglobin concentration continuously and noninvasively. Masimo Labs is using a technology that resembles the well accepted and clinically proven pulse-oxymeter.

The study will include surgical patients at the UCI Medical Center, preferably in cases that are known to involve major blood loss. For these cases, the anesthesia team places an arterial line for anesthesia purposes. The arterial line is used for continuous blood pressure measurements and blood draw for the assessment of several indices. We plan to compare the hemoglobin concentrations measured from blood samples to the Masimo Labs pulse-hemoglobin level readings.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Study Start Date : September 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : July 2009

Group/Cohort Intervention/treatment
Adult patient undergoing a surgery
Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes
Device: Masimo hemoglobin-meter
Placing a probe on the finger

Biological: drawing blood sample
drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)




Primary Outcome Measures :
  1. corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood sample for the measurement of Hct, and ABG


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients in UCI Medical Center undergoing surgery
Criteria

Inclusion Criteria:

  • Adult having surgery with arterial line

Exclusion Criteria:

  • Upper extremities surgery
  • Pregnant women
  • Children

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): NCT00762398


Locations
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United States, California
Univeristy of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Masimo Labs
Investigators
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Principal Investigator: Abraham Rosenbaum, MD University of California, Irvine
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Responsible Party: Abraham Rosenbaum, MD, Univesrtiy of California Irvine
ClinicalTrials.gov Identifier: NCT00762398    
Other Study ID Numbers: 2008-6221
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008
Keywords provided by University of California, Irvine:
Major surgery, excpected blood loss, arterial line