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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-04-30

Brief Summary

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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

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\*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

Conditions

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Major Spine Surgery Procedure

Keywords

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Major spine surgery Hemoglobin Blood transfusion

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ronald Wender

Chair of the anesthesia department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald H Wender, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00021287

Identifier Type: -

Identifier Source: org_study_id