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

NCT ID: NCT00319644

Last Updated: 2012-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilator-Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Minibal Arm

Using Mini bronchoalveolar lavage

Group Type EXPERIMENTAL

Bronchoalveolar lavage

Intervention Type DEVICE

Using catheter to obtain respiratory sample

Tracheal Aspirates

standard of care for ICU.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bronchoalveolar lavage

Using catheter to obtain respiratory sample

Intervention Type DEVICE

Other Intervention Names

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MiniBal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julin F Tang, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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27831-01

Identifier Type: -

Identifier Source: org_study_id