Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
This study has been completed.
Sponsor:
University of California, San Francisco
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventilator-Associated Pneumonia |
Device: Bronchoalveolar lavage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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
| Enrollment: | 37 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Minibal Arm
Using Mini bronchoalveolar lavage
|
Device: Bronchoalveolar lavage
Using catheter to obtain respiratory sample
Other Name: MiniBal
|
|
No Intervention: Tracheal Aspirates
standard of care for ICU.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319644
Locations
| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Julin F Tang, M.D., M.S. | University of California, San Francisco |
More Information
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 |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
ClinicalTrials.gov processed this record on May 22, 2013