Back to resultsImpact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
Primary Purpose
Ventilator-Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bronchoalveolar lavage
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilator-Associated Pneumonia
Eligibility Criteria
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
Sites / Locations
- San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Minibal Arm
Tracheal Aspirates
Arm Description
Using Mini bronchoalveolar lavage
standard of care for ICU.
Outcomes
Primary Outcome Measures
Change in Antibiotic Usage or Exposure
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
We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure
Secondary Outcome Measures
Full Information
NCT ID
NCT00319644
First Posted
April 27, 2006
Last Updated
October 16, 2012
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00319644
Brief Title
Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
Official Title
Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Associated Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minibal Arm
Arm Type
Experimental
Arm Description
Using Mini bronchoalveolar lavage
Arm Title
Tracheal Aspirates
Arm Type
No Intervention
Arm Description
standard of care for ICU.
Intervention Type
Device
Intervention Name(s)
Bronchoalveolar lavage
Other Intervention Name(s)
MiniBal
Intervention Description
Using catheter to obtain respiratory sample
Primary Outcome Measure Information:
Title
Change in Antibiotic Usage or Exposure
Description
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%).
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
Title
Antibiotics Exposure Days
Description
We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julin F Tang, M.D., M.S.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
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