NCT01221961

Terminated

Masimo Radical-7 Monitor a Useful Adjuvant During Major Spin...

Cedars-Sinai Medical Center Source

Cedars-Sinai Medical Center

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Pro00021287

Study Type

observational

Actual enrollment (reported)

62

Locations

1 country

Sites

1

Timeline

Study Start

October 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2013

Actual (reported)

Study Completion

April 2013

Actual (reported)

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)\*.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 62 participants
Study completion date: April 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 15, 2010
Actual (reported)
First Posted
October 18, 2010
Actual (reported)
Primary Completion
April 2013
Actual (reported)
Study Completion
April 2013
Actual (reported)

Last Updated: November 15, 2013
Status Verified: November 2013
Last Update Submitted: November 13, 2013

Conditions

Major Spine Surgery Procedure

Keywords

Major spine surgeryHemoglobinBlood transfusion

Outcome Measures

Primary Outcomes (1)

Hemoglobin value
During the time surgery last.
0-8 hours

Secondary Outcomes (1)

Blood transfusion
0-8 hours

Interventions

Masimo Radical-7Device

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients undergoing major spine surgery

You may qualify if:

Patients scheduled to undergo multiple level spine surgery procedures

Sponsors & Collaborators

Masimo Corporation
Industrycollaborator
Cedars-Sinai Medical Center
Otherlead

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Study Officials

Ronald H Wender, MD
Cedars-Sinai Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

62 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chair of the anesthesia department

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

October 2010

Date type not reported

This date has not been verified as actual or estimated.

years of age

American Society of Anesthesiologists (ASA) Class I - III adults of either sex

Pregnant women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

April 2013

Actual (reported)

Study Completion

April 2013

Actual (reported)

Last Updated

November 15, 2013

Record last verified: 2013-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01221961
Data provider: ClinicalTrials.gov
Source updated: 2013-11-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:52 UTC

Locations

US(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations