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Validation of Brain Oxygenation Monitor

This study has been completed.
Sponsor:
Collaborator:
Nonin Medical, Inc
Information provided by (Responsible Party):
David MacLeod, Duke University
ClinicalTrials.gov Identifier:
NCT00815490
First received: December 26, 2008
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Healthy
Intervention: Device: Desaturation

  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
Recruitment 10/2007 - 12/2008 at Duke University Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy volunteers recruited with specific exclusion of anemia & hemoglobinopathy.

Reporting Groups
  Description
Calibration Initial group of subjects on whom the test algorithm is developed.
Validation Group of subjects in whom the final algorithm is tested.

Participant Flow:   Overall Study
    Calibration     Validation  
STARTED     9     9  
COMPLETED     9     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Calibration Initial group of subjects on whom the test algorithm is developed.
Validation Group of subjects in whom the final algorithm is tested.
Total Total of all reporting groups

Baseline Measures
    Calibration     Validation     Total  
Number of Participants  
[units: participants]
 		  9     9     18  
Age [1]
[units: Years]
Mean ( Full Range ) 		  25  
  ( 21 to 31 )   		  26  
  ( 21 to 34 )   		  25.7  
  ( 21 to 34 )  
Gender  
[units: Participants]
 		     
Female     4     4     8  
Male     5     5     10  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Hispanic     1     0     1  
African American     1     1     2  
Caucasian     6     7     13  
Asian     1     1     2  
[1] Age



  Outcome Measures

1.  Primary:   Accuracy of Sensor   [ Time Frame: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period. ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
None  


Results Point of Contact:  
Name/Title: Dr David MacLeod
Organization: Duke University Medical Center
phone: 919-812-3201
e-mail: david.macleod@duke.edu


Publications of Results:


Responsible Party: David MacLeod, Duke University
ClinicalTrials.gov Identifier: NCT00815490     History of Changes
Other Study ID Numbers: Pro00002400
Study First Received: December 26, 2008
Results First Received: November 19, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board