Ventilator-Associated Pneumonia
Conditions
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.
Interventions
DEVICEBronchoalveolar lavage
Using catheter to obtain respiratory sample
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Antibiotic Usage or Exposure | 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 | 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 | 15 days | We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure |
Countries
United States
Participant flow
Recruitment details
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
Adult patients with suspected VAP were randomized to the mini-BAL (MB) diagnostic group or the tracheal aspirate (TA) diagnostic group.
Participants by arm
| Arm | Count |
|---|---|
| Minibal Arm Using Mini bronchoalveolar lavage | 16 |
| Tracheal Aspirates No intervention. Standard of care in ICU. | 21 |
| Total | 37 |
Baseline characteristics
| Characteristic | Tracheal Aspirates | Minibal Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 16 Participants | 37 Participants |
| Age Continuous | 52.81 years STANDARD_DEVIATION 19.3 | 49.38 years STANDARD_DEVIATION 16.3 | 51.09 years STANDARD_DEVIATION 27.45 |
| Region of Enrollment United States | 21 participants | 16 participants | 37 participants |
| Sex: Female, Male Female | 10 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 0 / 21 |
| serious Total, serious adverse events | 0 / 16 | 0 / 21 |
Outcome results
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
Time frame: 15 days
Population: Random
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mini-BAL | Antibiotics Exposure Days | 4 days | Standard Deviation 3.89 |
| Tracheal Aspirates | Antibiotics Exposure Days | 5.81 days | Standard Deviation 6.95 |
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%).
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mini-BAL | Change in Antibiotic Usage or Exposure | 11.87 days | Standard Deviation 13.8 |
| Tracheal Aspirates | Change in Antibiotic Usage or Exposure | 7.76 days | Standard Deviation 1.06 |
Comparison: The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.p-value: 0.26Chi-squared