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Clinical Trials/NCT01221961
NCT01221961
Terminated
Not Applicable

A Study to Determine the Agreement Between Masimo Monitor and Standard of Care

Cedars-Sinai Medical Center1 site in 1 country62 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Spine Surgery Procedure
Sponsor
Cedars-Sinai Medical Center
Enrollment
62
Locations
1
Primary Endpoint
Hemoglobin value
Status
Terminated
Last Updated
12 years ago

Overview

Brief Summary

This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb [Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)*.

Detailed Description

\*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
April 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ronald Wender

Chair of the anesthesia department

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled to undergo multiple level spine surgery procedures
  • 18 - 80 years of age
  • American Society of Anesthesiologists (ASA) Class I - III adults of either sex
  • Pregnant women

Exclusion Criteria

  • Patients with a perfusion index less than 1 or low confidence reading
  • Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement
  • Patient undergoing cardio-pulmonary bypass

Outcomes

Primary Outcomes

Hemoglobin value

Time Frame: 0-8 hours

During the time surgery last.

Secondary Outcomes

  • Blood transfusion(0-8 hours)

Study Sites (1)

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