- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01604668
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring.
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to compare the accuracy of the: 1) SpHb RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery. The results from the three sensors will be compared to a blood hemoglobin level taken intermittently (as a function of the patient's anesthesia care) and analyzed in the UCSF Clinical Laboratories.
This is an observational study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco Moffitt/Long Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 18 years of age
- ASA Classification 1, 2 or 3
- Scheduled to undergo spine surgery
Exclusion Criteria:
- Pregnant of nursing
- In the investigator's judgement would not be suitable for research
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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RevF vs RevG vs Pronto-7
Comparison of hemoglobin levels derived by continuous hemoglobin sensor RevF versus continuous hemoglobin sensor RevG versus an intermittent hemoglobin level derived from the Pronto-7 hand-held device versus a hemoglobin derived from a blood sample.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery.
Time Frame: Two or more measurements during surgery
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Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample.
A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery.
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Two or more measurements during surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Ronald D. Miller, MD, MS, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000524C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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