Ventilator Associated Tracheobronchitis in the First 14 Days in ICU

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Efstratios Manoulakas, University of Thessaly
ClinicalTrials.gov Identifier:
NCT01802827
First received: September 24, 2012
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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


Condition
Airway Colonization
Tracheobronchitis and Pneumonia Associated With Ventilator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • mortality [ Time Frame: mortality at 4 weeks ] [ Designated as safety issue: No ]
    we assessed mortality from all causes at 4 weeks


Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: expected average length of stay 15 days ] [ Designated as safety issue: No ]
  • mortality at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood, sputum


Enrollment: 236
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Efstratios Manoulakas, Ph, Principal Investigator, University of Thessaly
ClinicalTrials.gov Identifier: NCT01802827     History of Changes
Other Study ID Numbers: MARKAR236
Study First Received: September 24, 2012
Last Updated: February 28, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by University of Thessaly:
airway colonization
tracheobronchitis
pneumonia

Additional relevant MeSH terms:
Pneumonia
Bronchitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on July 22, 2014