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

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. Identifier: NCT00319644
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : November 16, 2012
Last Update Posted : November 16, 2012
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Ventilator-Associated Pneumonia
Intervention: Device: Bronchoalveolar lavage

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 16   21   37 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   16   21   37 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 49.38  (16.3)   52.81  (19.3)   51.09  (27.45) 
[Units: Participants]
Female   2   10   12 
Male   14   11   25 
Region of Enrollment 
[Units: Participants]
United States   16   21   37 

  Outcome Measures

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

  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
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  More Information

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: Julin Tang, MD
Organization: University of California, San Francisco
phone: 415-206-5274

Responsible Party: University of California, San Francisco Identifier: NCT00319644     History of Changes
Other Study ID Numbers: 27831-01
First Submitted: April 27, 2006
First Posted: April 27, 2006
Results First Submitted: March 24, 2011
Results First Posted: November 16, 2012
Last Update Posted: November 16, 2012