Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

University of California San Francisco (UCSF)

Status: Completed

Conditions: Blood Loss

Study type: Observational

Funder types: Other

Identifiers

NCT01604668

1000524C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

RevF vs RevG vs Pronto-7

Description:

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.