Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00319644
First received: April 27, 2006
Last updated: October 16, 2012
Last verified: October 2012
Results First Received: March 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Ventilator-Associated Pneumonia
Intervention: Device: Bronchoalveolar lavage

  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
Study was a randomized, controlled trial of adult patients admitted to the trauma/surgical intensive care unit of San Francisco General Hospital and was conducted from 5/1/2005 to August 15, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adult patients with suspected VAP were randomized to the mini-BAL (MB) diagnostic group or the tracheal aspirate (TA) diagnostic group.

Reporting Groups
  Description
Tracheal Aspirates No intervention. Standard of care in ICU.
Minibal Arm Using Mini bronchoalveolar lavage

Participant Flow:   Overall Study
    Tracheal Aspirates     Minibal Arm  
STARTED     21     16  
COMPLETED     21     16  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Minibal Arm Using Mini bronchoalveolar lavage
Tracheal Aspirates No intervention. Standard of care in ICU.
Total Total of all reporting groups

Baseline Measures
    Minibal Arm     Tracheal Aspirates     Total  
Number of Participants  
[units: participants]
  16     21     37  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     21     37  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49.38  ± 16.3     52.81  ± 19.3     51.09  ± 27.45  
Gender  
[units: participants]
     
Female     2     10     12  
Male     14     11     25  
Region of Enrollment  
[units: participants]
     
United States     16     21     37  



  Outcome Measures
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1.  Primary:   Change in Antibiotic Usage or Exposure   [ Time Frame: It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics ]

2.  Primary:   Antibiotics Exposure Days   [ Time Frame: 15 days ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Julin Tang, MD
Organization: University of California, San Francisco
phone: 415-206-5274
e-mail: tangj@anesthesia.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00319644     History of Changes
Other Study ID Numbers: 27831-01
Study First Received: April 27, 2006
Results First Received: March 24, 2011
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board