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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00319644

First received: April 27, 2006

Last updated: October 16, 2012

Last verified: October 2012

History of Changes

Results First Received: March 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Ventilator-Associated Pneumonia
Intervention:	Device: Bronchoalveolar lavage

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adult patients with suspected VAP were randomized to the mini-BAL (MB) diagnostic group or the tracheal aspirate (TA) diagnostic group.

Reporting Groups

	Description
Tracheal Aspirates	No intervention. Standard of care in ICU.
Minibal Arm	Using Mini bronchoalveolar lavage

Participant Flow: Overall Study

	Tracheal Aspirates	Minibal Arm
STARTED	21	16
COMPLETED	21	16
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Minibal Arm	Using Mini bronchoalveolar lavage
Tracheal Aspirates	No intervention. Standard of care in ICU.
Total	Total of all reporting groups

Baseline Measures

	Minibal Arm	Tracheal Aspirates	Total
Number of Participants [units: participants]	16	21	37
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	16	21	37
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	49.38 ± 16.3	52.81 ± 19.3	51.09 ± 27.45
Gender [units: participants]
Female	2	10	12
Male	14	11	25
Region of Enrollment [units: participants]
United States	16	21	37

Outcome Measures

Show All Outcome Measures

1. Primary:

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 ]

Show Outcome Measure 1

2. Primary:

Antibiotics Exposure Days [ Time Frame: 15 days ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Julin Tang, MD
Organization: University of California, San Francisco
phone: 415-206-5274
e-mail: tangj@anesthesia.ucsf.edu

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00319644 History of Changes
Other Study ID Numbers:	27831-01
Study First Received:	April 27, 2006
Results First Received:	March 24, 2011
Last Updated:	October 16, 2012
Health Authority:	United States: Institutional Review Board

To Top