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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

April 27, 2006
October 16, 2012
May 2006
December 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have >80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).
  • Antibiotics Exposure Days [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure
Not Provided
Complete list of historical versions of study NCT00319644 on ClinicalTrials.gov Archive Site
Not Provided
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Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia

The proposed study will evaluate adult patients admitted to the medical or surgical intensive care units (ICUs) at San Francisco General Hospital (SFGH). On admission, patients will be randomized in a 1:1 manner to the mini-bronchoalveolar lavage (BAL) quantitative culture arm in the setting of suspected ventilator-associated pneumonia (VAP) versus the tracheal aspirate culture arm, which is the current test available at SFGH.

Patients will be randomized to either Mini-Bal or tracheal aspirate then samples will be taken to the lab for culture. Comparative analysis will then be performed based upon lab results.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ventilator-Associated Pneumonia
Device: Bronchoalveolar lavage
Using catheter to obtain respiratory sample
Other Name: MiniBal
  • Experimental: Minibal Arm
    Using Mini bronchoalveolar lavage
    Intervention: Device: Bronchoalveolar lavage
  • No Intervention: Tracheal Aspirates
    standard of care for ICU.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All adult patients (> age 18) admitted to 5E, 5R, and 4E intensive care units and are on the ventilator for greater than 48 hours and expected to remain on the ventilator for awhile
  • Study procedures would be performed only in patients clinically suspected of having VAP.

Exclusion Criteria:

  • Severe respiratory distress at the time of suspected VAP defined by:

    • FiO2 ≥ 0.7
    • PEEP ≥ 12
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00319644
27831-01
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Julin F Tang, M.D., M.S. University of California, San Francisco
University of California, San Francisco
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP