Assessing the Accuracy of the RevK Sensor

Patients Undergoing Spine Surgery Clinical Trial

Official title:

Assessing the Accuracy of the RevK Sensor for Non-Invasive Hemoglobin Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877876
• Other study ID #: 10-00524E
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: June 8, 2015
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• 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

Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.

Description:

Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant female

• American Society of Anesthesiology Classification 1, 2 or 3

• Scheduled to undergo spine or hip surgery

Exclusion Criteria:

• Pregnant or nursing

• Patients who in the study investigators clinical judgement would not be suitable for research

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients Undergoing Spine Surgery

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No