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Comparison of Three Methods of Hemoglobin Monitoring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01284296
First received: January 19, 2011
Last updated: May 18, 2012
Last verified: May 2012
Results First Received: April 3, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Digital Block
Interventions: Drug: Lidocaine digital block
Device: Masimo SpHb continuous hemoglobin monitor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Digital Block The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.

Participant Flow:   Overall Study
    Digital Block  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Digital Block The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.

Baseline Measures
    Digital Block  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     8  
Gender  
[units: participants]
 
Female     12  
Male     8  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ronald D. Miller
Organization: University of California, San Francisco
phone: 415 476-9034
e-mail: millerr@anesthesia.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01284296     History of Changes
Other Study ID Numbers: 10-00524B
Study First Received: January 19, 2011
Results First Received: April 3, 2012
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board