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

NCT00319644 | Completed Results

• 1 other identifier: 27831-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-Associated Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Minibal Arm

EXPERIMENTAL

Using Mini bronchoalveolar lavage

Device: Bronchoalveolar lavage

Tracheal Aspirates

NO INTERVENTION

standard of care for ICU.

Interventions

Bronchoalveolar lavage DEVICE

Using catheter to obtain respiratory sample

Also known as: MiniBal

Minibal Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe respiratory distress at the time of suspected VAP defined by:
• FiO2 ≥ 0.7
• PEEP ≥ 12

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Results Point of Contact

• Title: Julin Tang, MD
• Organization: University of California, San Francisco

tangj@anesthesia.ucsf.edu

415-206-5274

Study Officials

• Julin F Tang, M.D., M.S.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 16, 2012
• Results First Posted: November 16, 2012

Record last verified: 2012-10

Locations

US (1)