Masimo Radical-7 Monitor a Useful Adjuvant During Major S... | NCT01221961

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

NCT01221961

Sponsor

Cedars-Sinai Medical Center

Status

Terminated

Last Update Posted

Nov 15, 2013Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Major Spine Surgery Procedure

Interventions

Masimo Radical-7

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We completed the 62% of the cases, enough data to get a conclusion of the study.

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Oct 15, 2010

First Submission Date that Met QC Criteria

Oct 15, 2010

First Posted Date

Oct 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2013

Last Update Posted Date

Nov 15, 2013Estimated

Name	Class
Masimo Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)*.](streamdown:incomplete-link)

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Masimo Radical-7	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing major spine surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald H Wender, MD	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical center		Los Angeles	California	90048	United States