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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minibal Arm | Experimental | Using Mini bronchoalveolar lavage |
|
| Tracheal Aspirates | No Intervention | standard of care for ICU. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoalveolar lavage | Device | Using catheter to obtain respiratory sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | 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 |
| Antibiotics Exposure Days | We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
Severe respiratory distress at the time of suspected VAP defined by:
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| Name | Affiliation | Role |
|---|---|---|
| Julin F Tang, M.D., M.S. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
Adult patients with suspected VAP were randomized to the mini-BAL (MB) diagnostic group or the tracheal aspirate (TA) diagnostic group.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Tracheal Aspirates | No intervention. Standard of care in ICU. |
| FG001 | Minibal Arm | Using Mini bronchoalveolar lavage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Minibal Arm | Using Mini bronchoalveolar lavage |
| BG001 | Tracheal Aspirates | No intervention. Standard of care in ICU. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%). | Of the 37 adult critically ill patients, 21 belonged to the tracheal aspirate (TA) group and 16 patients were classified as mini-BAL (MB) group. | Posted | Mean | Standard Deviation | days | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minibal Arm | Using Mini bronchoalveolar lavage |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Desaturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julin Tang, MD | University of California, San Francisco | 415-206-5274 | tangj@anesthesia.ucsf.edu |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mini-BAL |
BAL for quantitative culture as TA group. |
| OG001 | Tracheal Aspirates | No intervention. Standard of care in ICU. the aspirates were sent for micro culture. |
|
|
|
| Primary | Antibiotics Exposure Days | We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure | Random | Posted | Mean | Standard Deviation | days | 15 days |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Tracheal Aspirates | No intervention. Standard of care in ICU. | 0 | 21 | 0 | 21 |
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
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| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |