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

Terminated

• Conditions: Major Spine Surgery Procedure

• Registration Number: NCT01221961
• Lead Sponsor: Cedars-Sinai Medical Center

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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood transfusion	0-8 hours	During the time surgery last.

Trial Locations

Locations (1)

Cedars Sinai Medical center; 🇺🇸 Los Angeles, California, United States