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NCT01604668 Clinical Trial

Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

Blood Loss Clinical Trial

Official title:
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01604668
Other study ID # 1000524C
Secondary ID
Status Completed
Phase N/A
First received May 18, 2012
Last updated August 19, 2013
Start date May 2012
Est. completion date May 2013

Study information
Verified date August 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California, San Francisco Moffitt/Long Hospitals San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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