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Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01604668
First received: May 18, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604668

Contacts
Contact: Ronald D. Miller, MD, MS (415) 476-9034 millerr@anesthesia.ucsf.edu
Contact: Theresa A. Ward, BSN, RN (415) 514-0685 wardt@anesthesia.ucsf.edu

Locations
United States, California
University of California, San Francisco Moffitt/Long Hospitals Recruiting
San Francisco, California, United States, 94143
Contact: Theresa A. Ward, BSN, RN     415-514-0685     wardt@anesthesia.ucsf.edu    
Principal Investigator: Ronald D. Miller, MD, MS            
Sub-Investigator: Theresa A. Ward, BSN, RN            
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: May 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013