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Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01604668
First received: May 18, 2012
Last updated: August 19, 2013
Last verified: August 2013
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Purpose
There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1) SpHb (Radical 7 Pulse Co-Oximetry with 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.
| Condition |
|---|
| Blood Loss |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring. |
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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 ]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.
| Enrollment: | 10 |
| Study Start Date: | May 2012 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients undergoing spine surgery
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604668
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604668
Locations
| United States, California | |
| University of California, San Francisco Moffitt/Long Hospitals | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Ronald D. Miller, MD, MS | University of California, San Francisco |
More Information
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01604668 History of Changes |
| Other Study ID Numbers: |
1000524C |
| Study First Received: | May 18, 2012 |
| Last Updated: | August 19, 2013 |
ClinicalTrials.gov processed this record on September 21, 2017