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Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery

This study has been terminated.
(We completed the 62% of the cases, enough data to get a conclusion of the study.)
Sponsor:
Collaborator:
Masimo Corporation
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01221961
First received: October 15, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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)*.


Condition Intervention
Major Spine Surgery Procedure
Device: Masimo Radical-7

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Study to Determine the Agreement Between Masimo Monitor and Standard of Care

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Hemoglobin value [ Time Frame: 0-8 hours ] [ Designated as safety issue: No ]
    During the time surgery last.


Secondary Outcome Measures:
  • Blood transfusion [ Time Frame: 0-8 hours ] [ Designated as safety issue: No ]
    During the time surgery last.


Enrollment: 62
Study Start Date: October 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Masimo Radical-7
    The Masimo device will be placed on one finger of the patient. To 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
    Other Name: Masimo Radical-7
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing major spine surgery

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221961

Locations
United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Masimo Corporation
Investigators
Principal Investigator: Ronald H Wender, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Ronald Wender, Chair of the anesthesia department, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01221961     History of Changes
Other Study ID Numbers: Pro00021287
Study First Received: October 15, 2010
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Major spine surgery
Hemoglobin
Blood transfusion

ClinicalTrials.gov processed this record on November 24, 2014