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Ventilator Associated Tracheobronchitis in the First 14 Days in ICU

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: NCT01802827
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.

Condition or disease
Airway Colonization Tracheobronchitis and Pneumonia Associated With Ventilator

Study Design

Study Type : Observational
Actual Enrollment : 236 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2009
Primary Completion Date : March 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
VAT patients
Patients developing Ventilator Associated Tracheobronchitis
VAP
Patients presenting ventilator associated pneumonia
No ventilator associated infection
patients who do not present ventilator associated infection during their stay in ICU


Outcome Measures

Primary Outcome Measures :
  1. mortality [ Time Frame: mortality at 4 weeks ]
    we assessed mortality from all causes at 4 weeks


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: expected average length of stay 15 days ]
  2. mortality at 6 months [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
blood, sputum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients ventilated > 48hours
Criteria

Inclusion Criteria:

  • > 48 hours mechanical ventilation

Exclusion Criteria:

  • immunodeficiency
  • pregnancy
  • severe COPD, chronic bronchitis, bronchiectasis
  • recent pneumonia
More Information

Responsible Party: Efstratios Manoulakas, Ph, Principal Investigator, University of Thessaly
ClinicalTrials.gov Identifier: NCT01802827     History of Changes
Other Study ID Numbers: MARKAR236
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013

Keywords provided by Efstratios Manoulakas, University of Thessaly:
airway colonization
tracheobronchitis
pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections