Ventilator Associated Tracheobronchitis in the First 14 Days in ICU

February 28, 2013 updated by: Efstratios Manoulakas, University of Thessaly
To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients ventilated > 48hours

Description

Inclusion Criteria:

  • > 48 hours mechanical ventilation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: mortality at 4 weeks
we assessed mortality from all causes at 4 weeks
mortality at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality at 6 months
Time Frame: 6 months
6 months
ICU length of stay
Time Frame: expected average length of stay 15 days
expected average length of stay 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARKAR236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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