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Completed

NCT Number: NCT00319644

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.

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Key information

Conditions

Ventilator-associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoalveolar lavage

Device

Using catheter to obtain respiratory sample

Other names: MiniBal

Primary outcomes

  1. 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

    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%).

  2. Antibiotics Exposure Days

    Time frame: 15 days

    We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 27, 2006
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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