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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01221961

Enrollment

Registered

2010-10-18

Start date

2010-10-31

Completion date

2013-04-30

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Spine Surgery Procedure

Keywords

Major spine surgery, Hemoglobin, Blood transfusion

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

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hemoglobin value	0-8 hours	During the time surgery last.

Secondary

Measure	Time frame	Description
Blood transfusion	0-8 hours	During the time surgery last.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026