Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
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Purpose
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)*.
| Condition | Intervention |
|---|---|
|
Major Spine Surgery Procedure |
Device: Masimo Radical-7 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Study to Determine the Agreement Between Masimo Monitor and Standard of Care |
- Hemoglobin value [ Time Frame: 0-8 hours ] [ Designated as safety issue: No ]During the time surgery last.
- Blood transfusion [ Time Frame: 0-8 hours ] [ Designated as safety issue: No ]During the time surgery last.
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Device: Masimo Radical-7
*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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing major spine surgery
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
Contacts and Locations| Contact: Paul F White, MD, PhD | 650-5591754 | whitemountaininstitute@hotmail.com |
| Contact: Ofelia L Elvir-Lazo, MD | 310-7214414 | loanidoc@yahoo.com |
| United States, California | |
| Cedars Sinai Medical center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Ronald H Wender, MD 310-423-5841 Ronald.Wender@cshs.org | |
| Contact: Ofelia L Elvir-Lazo, MD 310-4234414 loanidoc@yahoo.com | |
| Principal Investigator: | Ronald H Wender, MD | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | Ronald H. Wender MD., Cedars Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT01221961 History of Changes |
| Other Study ID Numbers: | Pro00021287 |
| Study First Received: | October 15, 2010 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
Major spine surgery Hemoglobin Blood transfusion |
ClinicalTrials.gov processed this record on May 23, 2013