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

November 13, 2013 updated by: Ronald Wender, Cedars-Sinai Medical Center

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

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)*.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing major spine surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin value
Time Frame: 0-8 hours
During the time surgery last.
0-8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood transfusion
Time Frame: 0-8 hours
During the time surgery last.
0-8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 15, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00021287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Spine Surgery Procedure

Clinical Trials on Masimo Radical-7

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe