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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

Tracking Information
First Submitted Date September 26, 2008
First Posted Date September 30, 2008
Last Update Posted Date September 30, 2008
Study Start Date September 2008
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2008)
corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Official Title Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Brief Summary The Masimo monitor can measure hemoglobin level noninvasively and accuratly
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample for the measurement of Hct, and ABG
Sampling Method Non-Probability Sample
Study Population Adult patients in UCI Medical Center undergoing surgery
Condition Adult Patient Undergoing Major Surgery
Intervention
  • 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)
Study Groups/Cohorts Adult patient undergoing a surgery
Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes
Interventions:
  • Device: Masimo hemoglobin-meter
  • Biological: drawing blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 29, 2008)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2009
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult having surgery with arterial line

Exclusion Criteria:

  • Upper extremities surgery
  • Pregnant women
  • Children
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00762398
Other Study ID Numbers 2008-6221
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abraham Rosenbaum, MD, Univesrtiy of California Irvine
Study Sponsor University of California, Irvine
Collaborators Masimo Labs
Investigators
Principal Investigator: Abraham Rosenbaum, MD University of California, Irvine
PRS Account University of California, Irvine
Verification Date September 2008