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TerminatedNCT01221961Updated Nov 15, 2013

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

An observational study in Major Spine Surgery Procedure, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-15.

Sponsored by Cedars-Sinai Medical Center · Observational

Why this study was terminated
We completed the 62% of the cases, enough data to get a conclusion of the study.
Study type
Observational
Time perspective
Prospective
Enrollment
62
Ages
18 Years to 80 Years
Sex
All
01

Study 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)*.

Read the 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

02

Conditions studied

  • Major Spine Surgery Procedure

Keywords

  • Major spine surgery
  • Hemoglobin
  • Blood transfusion
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing major spine surgery

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

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
05

Study design

Time perspective
Prospective
Enrollment
62 participants (actual)

Interventions

  • DeviceMasimo 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

06

What researchers measure

Primary outcomes

  1. Hemoglobin value

    During the time surgery last.

    Time frame: 0-8 hours

Secondary outcomes

  1. Blood transfusion

    During the time surgery last.

    Time frame: 0-8 hours

07

Study locations

1 site
  • Cedars Sinai Medical center
    Los Angeles, California 90048, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01221961
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
Masimo Corporation
Responsible party
Ronald Wender (Chair of the anesthesia department, Cedars-Sinai Medical Center) — Principal investigator
First posted
Oct 18, 2010
Start date
Oct 2010
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Nov 15, 2013

Study contacts

Ronald H Wender, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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