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BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Annette R. McClinton, United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00351741
First received: July 11, 2006
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
Results First Received: July 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Burns
Interventions: Device: Ventilation - High Frequency Percussive Ventilation
Device: Ventilation - ARDSnet

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
High Frequency Intervention with high frequency percussive ventilation
Conventional Low-tidal volume ventilation
Total Total of all reporting groups

Baseline Measures
    High Frequency     Conventional     Total  
Number of Participants  
[units: participants]
 		  31     31     62  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     29     29     58  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation 		  35  ± 18     37  ± 18     36  ± 18  
Gender  
[units: participants]
 		     
Female     4     5     9  
Male     27     26     53  
Region of Enrollment  
[units: participants]
 		     
United States     31     31     62  



  Outcome Measures
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1.  Primary:   Ventilator-free Days During the First 28 Days   [ Time Frame: 28 days ]
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2.  Secondary:   Days Free From Nonpulmonary Organ Failure   [ Time Frame: 28 ]
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3.  Secondary:   Death   [ Time Frame: during hospitalization ]
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4.  Secondary:   Ventilator Associated Pneumonia   [ Time Frame: 28 days ]
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5.  Secondary:   Need for Rescue Ventilator   [ Time Frame: 28 days ]
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6.  Secondary:   Barotrauma   [ Time Frame: 28 days ]
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7.  Secondary:   Ventilator Associated Tracheobronchitis (VATB)   [ Time Frame: checked daily ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
After 3 yrs of enrollment, interim analysis revealed a significant number of subjects in the Conventional arm required rescue, which served as the trigger to close the study to further enrollment.  


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: USAISR
phone: 210-916-3054
e-mail: kevin.chung@us.army.mil


Publications:

Publications automatically indexed to this study:


Responsible Party: Annette R. McClinton, United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00351741     History of Changes
Other Study ID Numbers: H-06-005
Study First Received: July 11, 2006
Results First Received: July 16, 2010
Last Updated: December 10, 2012
Health Authority: United States: Federal Government