Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

NCT01604668 | Completed DMC

• 1 other identifier: 1000524C
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Two or more measurements during surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing spine surgery

You may qualify if:

• ≥ 18 years of age
• ASA Classification 1, 2 or 3
• Scheduled to undergo spine surgery

You may not qualify if:

• Pregnant of nursing
• In the investigator's judgement would not be suitable for research

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco Moffitt/Long Hospitals

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.

  PMID: 21385985 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald D. Miller, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 24, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

US (1)