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Comparison of Three Methods of Hemoglobin Monitoring

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ClinicalTrials.gov Identifier: NCT01284296
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : April 4, 2012
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 19, 2011
First Posted Date  ICMJE January 26, 2011
Results First Submitted Date  ICMJE April 3, 2012
Results First Posted Date  ICMJE April 4, 2012
Last Update Posted Date May 28, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. [ Time Frame: A minimum of 2-4 differences recorded approximately hourly during surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
SpHb - tHb [ Time Frame: A minimum of three differences recorded approximately hourly during surgery ]
Difference between the SpHb (Masimo SpHb™ continuous hemoglobin reading ) - tHb (laboratory hemoglobin).
Change History Complete list of historical versions of study NCT01284296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Three Methods of Hemoglobin Monitoring
Official Title  ICMJE Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine or Hip Surgery
Brief Summary This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).
Detailed Description

We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor.

The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Digital Block
Intervention  ICMJE
  • Drug: Lidocaine digital block
    One dose of lidocaine 2% injected locally into one finger (2 mls total)
  • Device: Masimo SpHb continuous hemoglobin monitor
    Masimo SpHb continuous hemoglobin monitor
Study Arms  ICMJE Experimental: Digital block
Interventions:
  • Drug: Lidocaine digital block
  • Device: Masimo SpHb continuous hemoglobin monitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non-pregnant female 18 y/o or older
  • ASA Classification 1, 2 or 3
  • Scheduled to undergo spine or hip revision surgery

Exclusion Criteria:

  • Pregnant or nursing
  • Patients who in the study investigators clinical judgement would not be suitable for research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01284296
Other Study ID Numbers  ICMJE 10-00524B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald D Miller, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP