Major Spine Surgery ProcedureNCT01221961
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
An observational study of Major Spine Surgery Procedure, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Spine Surgery Procedure
- What is being tested?
- Masimo Radical-7
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major spine surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical center
Los Angeles, California, 90048
About this study
Official title: A Study to Determine the Agreement Between Masimo Monitor and Standard of Care
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)*.
Read the 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
- Conditions
- Major Spine Surgery Procedure
- Being tested
- Masimo Radical-7
- Keywords
- Major spine surgery, Hemoglobin, Blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin value
During the time surgery last.
Measured: 0-8 hours
Secondary outcomes (1)
Blood transfusion
During the time surgery last.
Measured: 0-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: We completed the 62% of the cases, enough data to get a conclusion of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Spine Surgery ProcedureStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, Ronald Wender, Cedars-Sinai Medical Center
- Investigators
- Ronald H Wender, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221961
- Sponsor's protocol ID
- Pro00021287
- Status last verified
- Nov 2013
- First submitted
- 15 Oct 2010
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Agreement Between Masimo Monitor and Standard of Care
- ClinicalTrials.gov ID
- NCT01221961
- Acronym / sponsor ID
- Pro00021287
- Conditions
- Major Spine Surgery Procedure
- Keywords
- Major spine surgery, Hemoglobin, Blood transfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We completed the 62% of the cases, enough data to get a conclusion of the study.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major spine surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Radical-7The 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 | Device | – |
Primary outcome
Hemoglobin value
Time frame: 0-8 hours
During the time surgery last.
1 secondary outcome
Blood transfusion
Time frame: 0-8 hours
Results and safety
The study was stopped early (reason given: We completed the 62% of the cases, enough data to get a conclusion of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Related trials for Major Spine Surgery Procedure
Recruiting
Evaluation of the Effect of Reiki on Pain After Lumbar Surgery
The Lumbar Spine Surgical Intervention, Arthrodesis
RecruitingObservational study
Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)
Spinal Fusion
RecruitingPhase 4
Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
Post Operative Pain, Spinal Surgery
RecruitingPhase 4
Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery.
Pain, Postoperative, Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald H Wender, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Spine Surgery Procedure, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We completed the 62% of the cases, enough data to get a conclusion of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin value (time frame: 0-8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.