Study of the Influence of Various Tidal Volumes on Exhaled Breath Condensate (EBC) in Mechanically Ventilated Patients (TDEBC)

This study has been completed.
Sponsor:
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Apostolopoulou Olympia, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT00910026
First received: May 28, 2009
Last updated: October 24, 2013
Last verified: November 2009
  Purpose

The aim of the present study is to evaluate the effect of low (6 ml/kg) and high (12 ml/kg) tidal volume ventilation on inflammatory and oxidative stress biomarkers in the exhaled breath condensate (EBC) of ICU patients without lung injury. As the analysis of EBC is reflecting the composition of epithelial lining fluid (ELF), the study of EBC pH and inflammatory and oxidative stress markers could have the potential for assessing lung inflammation caused by mechanical ventilation. This study also aims to look at the possibility to identify selective profiles of biomarkers that might have a prognostic and/or diagnostic value in the follow up of these patients.


Condition Intervention
Inflammation
Procedure: low tidal volume ventilation
Procedure: high tidal volume ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Exhaled Breath Condensate (EBC) Collection and Analysis in Mechanically Ventilated ICU Patients: Monitoring of the Influence of Various Tidal Volumes on Lung Inflammatory Biomarkers

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Evaluation of the effect of low (6 ml/kg) and high (12 ml/kg) tidal volume ventilation on inflammatory and oxidative stress biomarkers in the exhaled breath condensate (EBC) of ICU patients without lung injury. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the prognostic role of exhaled biomarkers in the subsequent outcome of mechanically ventilated patients (length of ICU hospitalization, subsequent development of ALI or ARDS and morbidity and mortality in the ICU). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low tidal volume ventilation
6 ml/kg tidal volume ventilation
Procedure: low tidal volume ventilation
6 ml/kg tidal volume ventilation
Experimental: high tidal volume ventilation
12 ml/kg tidal volume ventilation
Procedure: high tidal volume ventilation
12 ml/kg tidal volume ventilation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU patients mechanically ventilated because of stroke, subarachnoid and/or intracerebral hemorrhage
  • Healthy respiratory system

Exclusion Criteria:

  • Pulmonary diseases
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00910026

Locations
Greece
Intensive Care Unit Department of University Hospital of Larissa
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
University of Thessaly
Investigators
Principal Investigator: Olympia I. Apostolopoulou, MD University of Thessaly
  More Information

Publications:
14. Murray JF, Matthay MA, et al; An expanded definition of the ARDS; Am rev Respir Dis 1988; 138: 720-723.
23. Hammerschmidt S., Meybaum M., Schauer J. et. al; Effect of tidal volume and end expiratory pressure on pulmonary NO release in an isolated lung model (abstract); Eur.Respir.J. 2001;18(suppl):366s.
35. The ARDS Network; Ventilation with lower tidal volumes compared with traditional tidal volumes for ALI and the ARDS; N. Engl. J Med 342;1334-1349, 2000.

Responsible Party: Apostolopoulou Olympia, MD, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT00910026     History of Changes
Other Study ID Numbers: 4163/02-09-2008
Study First Received: May 28, 2009
Last Updated: October 24, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Larissa University Hospital:
EBC and mechanical ventilation
low tidal volume ventilation
high tidal volume ventilation
inflammatory and oxidative stress EBC biomarkers
Ventilator induced lung injury

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014