Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

Completed

• Conditions: Blood Loss

• Registration Number: NCT01604668
• Lead Sponsor: University of California, San Francisco

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.

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of California, San Francisco Moffitt/Long Hospitals; 🇺🇸 San Francisco, California, United States