Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02363023
Recruitment Status : Terminated (Lack of resources.)
First Posted : February 13, 2015
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Rodrigo Miquelanti Melo, Federal University of Uberlandia

Brief Summary:
The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator associated pneumonia and their impact in morbimortality.

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Procedure: Collect tracheal and pulmonary secretions

Detailed Description:

Ventilator associated pneumonia is defined as one that occurs 48-72h after tracheal intubation, is classified into early and late and is responsible for a mortality of 24-50% to almost 70% in some studies.

The clinical suspicion of ventilator associated pneumonia is based on the finding of new or progressive pulmonary opacity associated with two or more variables such as: fever, leukocytosis or leukopenia, and purulent pulmonary secretions.

Some studies show that the etiologic diagnosis reduces spectrum of antimicrobials and bacterial resistance, reducing hospital stay and time of mechanical ventilation, as well as treatment costs. The collection of material for quantitative culture ensures greater specificity however there is no standard method.

The investigator's hypothesis is that collection of material to confirm the etiologic diagnosis of ventilator associated pneumonia, held by bronchoscopic bronchoalveolar lavage, define the etiology in a larger number of patients when compared to the endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage.

The primary goal is evaluate and compare the sensitivity and specificity of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive (bronchoscopic bronchoalveolar lavage) regarding the collection of material for etiologic diagnosis.

The secondary objectives are determine the prevalence of ventilator associated pneumonia and antimicrobial susceptibility patterns of bacteria isolated, helping to update empirical antibiotic therapy protocols.

This is a prospective comparative observational study on etiologic methods of diagnosis. All the patients, with clinical suspicion, will be submitted to collection of tracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. These procedures are already incorporated in the daily practice of our intensive cara unit and are routinely performed for investigation of patients with compatible framework of ventilator associated pneumonia, as availability of bronchoscopist.

Whereas an analysis of variance will be performed to compare the three interventions, with a minimum difference between the treatment means, a power of 0.95 and a significance level of 0.05, with an estimation error of 0.1, will be required a total sample of 72 patients.There will be only one group of 72 patients, in which will be held in all the three samples of the study.


Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparative Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
VAP suspects
Collect tracheal and pulmonary secretions. All patients (n: 72) will be submitted to endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage.
Procedure: Collect tracheal and pulmonary secretions
Collect tracheal and pulmonary secretions (endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage)




Primary Outcome Measures :
  1. Sensitivity, specificity and accuracy [ Time Frame: 30 days ]

    Sensitivity, specificity and accuracy of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive method (bronchoscopic bronchoalveolar lavage, considered gold standard).

    Sensitivity: number of true positive cultures obtained with each noninvasive method divided by the number of positive cultures obtained from bronchoscopic bronchoalveolar lavage;

    Specificity: number of true negative cultures obtained with each noninvasive method divided by the number of negative cultures obtained from bronchoscopic bronchoalveolar lavage;

    Accuracy: number of true positive plus true negative cultures obtained with each noninvasive method divided by the number of patients (72);



Secondary Outcome Measures :
  1. Prevalence of ventilator associated pneumonia (cases / time period) [ Time Frame: 10 months ]
    Number of cases of ventilator associated pneumonia divided by the number of months. We hope to reach the number of 72 patients in up to 10 months.

  2. Antimicrobial susceptibility patterns of bacteria isolated [ Time Frame: 72-96 hours ]
    All isolated bacteria will be submitted to tests for antimicrobial susceptibility and resistance pattern.


Biospecimen Retention:   Samples Without DNA
All positive cultures.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients older than 18 years admitted to the ICU of Hospital de Clínicas de Uberlândia with suspected VAP will be included in the project. from february 2015 to complete the total of 72 patients required, since provided that agree with the terms of informed consent.
Criteria

Inclusion Criteria:

  • Older than 18 and clinical suspicion of VAP;

Exclusion Criteria:

  • Age less than 18 years;
  • Introduction or modification of antibiotic therapy due to associated diagnosis in the first 3 days of the start of the protocol;
  • No agreement with informed consent or for any other reason, expose the desire to leave the protocol at any time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363023


Locations
Layout table for location information
Brazil
Rodrigo Miquelanti Melo
Uberlandia, Minas Gerais, Brazil, 38405320
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Layout table for investigator information
Principal Investigator: Rodrigo Melo Federal University of Uberlandia

Publications:

Layout table for additonal information
Responsible Party: Rodrigo Miquelanti Melo, Thoracic Surgeon, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT02363023     History of Changes
Other Study ID Numbers: VAP protocol
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are still collecting data.

Keywords provided by Rodrigo Miquelanti Melo, Federal University of Uberlandia:
Ventilator associated pneumonia
Bronchoalveolar lavage

Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection