Study Stopped
We completed the 62% of the cases, enough data to get a conclusion of the study.
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
A Study to Determine the Agreement Between Masimo Monitor and Standard of Care
1 other identifier
observational
62
1 country
1
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)\*.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 15, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 15, 2013
November 1, 2013
2.5 years
October 15, 2010
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin value
During the time surgery last.
0-8 hours
Secondary Outcomes (1)
Blood transfusion
0-8 hours
Interventions
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
Eligibility Criteria
Patients undergoing major spine surgery
You may qualify if:
- Patients scheduled to undergo multiple level spine surgery procedures
- 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.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- Masimo Corporationcollaborator
Study Sites (1)
Cedars Sinai Medical center
Los Angeles, California, 90048, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald H Wender, MD
Cedars-Sinai Medical Center
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 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 15, 2013
Record last verified: 2013-11