Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia

• ClinicalTrials.gov Identifier: NCT00319644
• Recruitment Status: Completed
• First Posted: April 27, 2006
• Results First Posted: November 16, 2012
• Last Update Posted: November 16, 2012
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

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.

Condition or disease	Intervention/treatment	Phase
Ventilator-Associated Pneumonia	Device: Bronchoalveolar lavage	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia
• Study Start Date: May 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00319644
• Other Study ID Numbers: 27831-01
• First Posted: April 27, 2006
• Results First Posted: November 16, 2012
• Last Update Posted: November 16, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Pneumonia; Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes