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Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

This study has been completed.
Sponsor:
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
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.
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
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
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, see Learn About Clinical Studies.

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
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 01, 2015