Assessing the Accuracy of the RevK Sensor
1 other identifier
observational
8
1 country
1
Brief Summary
Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 10, 2015
June 1, 2015
1.5 years
May 28, 2013
June 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value.
Primary outcome is based on the difference between a value from the SpHb (Masimo SpHb™ continuous hemoglobin reading) minus tHb (laboratory hemoglobin determination).
Intermittently during spine surgery
Study Arms (1)
Patient undergoing spine surgery
Eligibility Criteria
Patients undergoing spine surgery
You may qualify if:
- Male or non-pregnant female
- American Society of Anesthesiology Classification 1, 2 or 3
- Scheduled to undergo spine or hip surgery
You may not qualify if:
- Pregnant or nursing
- Patients who in the study investigators clinical judgement would not be suitable for research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald D Miller, MD, MS
University of California, San Francisco
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2013
First Posted
June 14, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
June 10, 2015
Record last verified: 2015-06