Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01604668 |
Recruitment Status :
Completed
First Posted : May 24, 2012
Last Update Posted : August 21, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Blood Loss |
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 : | Observational |
Actual Enrollment : | 10 participants |
Observational Model: | Cohort |
Official Title: | Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring. |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |
Group/Cohort |
---|
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.
|
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604668
United States, California | |
University of California, San Francisco Moffitt/Long Hospitals | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Ronald D. Miller, MD, MS | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01604668 |
Other Study ID Numbers: |
1000524C |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | August 21, 2013 |
Last Verified: | August 2013 |
Hemorrhage Pathologic Processes |