Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Three Methods of Hemoglobin Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Digital Block
Interventions Drug: Lidocaine digital block
Device: Masimo SpHb continuous hemoglobin monitor
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Digital Block
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Digital Block
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  60.0%
>=65 years
8
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
12
  60.0%
Male
8
  40.0%
1.Primary Outcome
Title Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.
Hide Description [Not Specified]
Time Frame A minimum of 2-4 differences recorded approximately hourly during surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Digital Block (All Perfusion Indices 0.29-8.3) Digital Block (Perfusion Indices >2.0)
Hide Arm/Group Description:
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.
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. This is a subgroup of differences with the perfusion index >2.0
Overall Number of Participants Analyzed 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Hemoglobin readings
57 35
Measure Type: Number
Unit of Measure: percentage of hemoglobin readings
< 0.5 g/dL 37 37
0.5-1.0 g/dL 19 26
1.1-1.5 g/dL 18 20
1.6-2.0 g/dL 17 14
>2.0 g/dL 9 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digital Block
Hide Arm/Group Description 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.
All-Cause Mortality
Digital Block
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Digital Block
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Digital Block
Affected / at Risk (%)
Total   0/20 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Ronald D. Miller
Organization: University of California, San Francisco
Phone: 415 476-9034
EMail: millerr@anesthesia.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01284296     History of Changes
Other Study ID Numbers: 10-00524B
First Submitted: January 19, 2011
First Posted: January 26, 2011
Results First Submitted: April 3, 2012
Results First Posted: April 4, 2012
Last Update Posted: May 28, 2012