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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Larissa University Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborator:

University of Thessaly

Information provided by:

Larissa University Hospital

ClinicalTrials.gov Identifier:

NCT00910026

First received: May 28, 2009

Last updated: November 2, 2009

Last verified: November 2009

History of Changes

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:	50
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910026

Contacts

Contact: Epaminondas Zakynthinos, Professor	00302410681240	ezakynth@yahoo.com
Contact: Kostantinos Kostikas, MD,FCCP	00302410670240	ktk@otenet.gr

Locations

Greece
Intensive Care Unit Department of University Hospital of Larissa	Recruiting
Larissa, Thessaly, Greece, 41110
Contact: Epaminondas Zakynthinos, Professor 00302410681240 ezakynth@yahoo.com
Contact: Konstantinos Kostikas, MD, FCCP 00302410670240 ktk@otenet.gr
Principal Investigator: Olympia Apostolopoulou, MD

Sponsors and Collaborators

Larissa University Hospital

University of Thessaly

Investigators

Principal Investigator:

Olympia I. Apostolopoulou, MD

University of Thessaly

More Information

Publications:

Holz O. Catching breath: monitoring airway inflammation using exhaled breath condensate. Eur Respir J. 2005 Sep;26(3):371-2. No abstract available.

Hunt J. Exhaled breath condensate: an evolving tool for noninvasive evaluation of lung disease. J Allergy Clin Immunol. 2002 Jul;110(1):28-34. Review.

Mutlu GM, Garey KW, Robbins RA, Danziger LH, Rubinstein I. Collection and analysis of exhaled breath condensate in humans. Am J Respir Crit Care Med. 2001 Sep 1;164(5):731-7. Review. No abstract available.

Kharitonov SA, Barnes PJ. Exhaled markers of pulmonary disease. Am J Respir Crit Care Med. 2001 Jun;163(7):1693-722. Review. No abstract available.

Muller WG, Morini F, Eaton S, Peters M, Jaffe A. Safety and feasibility of exhaled breath condensate collection in ventilated infants and children. Eur Respir J. 2006 Sep;28(3):479-85. Epub 2006 Apr 26.

Moloney ED, Mumby SE, Gajdocsi R, Cranshaw JH, Kharitonov SA, Quinlan GJ, Griffiths MJ. Exhaled breath condensate detects markers of pulmonary inflammation after cardiothoracic surgery. Am J Respir Crit Care Med. 2004 Jan 1;169(1):64-9. Epub 2003 Oct 9.

Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48.

Thammanomai A, Majumdar A, Bartolák-Suki E, Suki B. Effects of reduced tidal volume ventilation on pulmonary function in mice before and after acute lung injury. J Appl Physiol. 2007 Nov;103(5):1551-9. Epub 2007 Aug 9.

Halter JM, Steinberg JM, Gatto LA, DiRocco JD, Pavone LA, Schiller HJ, Albert S, Lee HM, Carney D, Nieman GF. Effect of positive end-expiratory pressure and tidal volume on lung injury induced by alveolar instability. Crit Care. 2007;11(1):R20.

Del Sorbo L, Slutsky AS. Year in review 2007: Critical Care - respirology. Crit Care. 2008;12(5):231. Epub 2008 Oct 14.

Dreyfuss D, Saumon G. From ventilator-induced lung injury to multiple organ dysfunction? Intensive Care Med. 1998 Feb;24(2):102-4. No abstract available.

Parker JC, Hernandez LA, Peevy KJ. Mechanisms of ventilator-induced lung injury. Crit Care Med. 1993 Jan;21(1):131-43. Review.

Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54.

14. Murray JF, Matthay MA, et al; An expanded definition of the ARDS; Am rev Respir Dis 1988; 138: 720-723.

Pelosi P, Negrini D. Extracellular matrix and mechanical ventilation in healthy lungs: back to baro/volotrauma? Curr Opin Crit Care. 2008 Feb;14(1):16-21. Review.

Vaughan J, Ngamtrakulpanit L, Pajewski TN, Turner R, Nguyen TA, Smith A, Urban P, Hom S, Gaston B, Hunt J. Exhaled breath condensate pH is a robust and reproducible assay of airway acidity. Eur Respir J. 2003 Dec;22(6):889-94.

Kostikas K, Papatheodorou G, Ganas K, Psathakis K, Panagou P, Loukides S. pH in expired breath condensate of patients with inflammatory airway diseases. Am J Respir Crit Care Med. 2002 May 15;165(10):1364-70.

Kostikas K, Papatheodorou G, Psathakis K, Panagou P, Loukides S. Oxidative stress in expired breath condensate of patients with COPD. Chest. 2003 Oct;124(4):1373-80.

van Beurden WJ, Harff GA, Dekhuijzen PN, van den Bosch MJ, Creemers JP, Smeenk FW. An efficient and reproducible method for measuring hydrogen peroxide in exhaled breath condensate. Respir Med. 2002 Mar;96(3):197-203.

Razola SS, Ruiz BL, Diez NM, Mark HB Jr, Kauffmann JM. Hydrogen peroxide sensitive amperometric biosensor based on horseradish peroxidase entrapped in a polypyrrole electrode. Biosens Bioelectron. 2002 Dec;17(11-12):921-8.

Montuschi P, Collins JV, Ciabattoni G, Lazzeri N, Corradi M, Kharitonov SA, Barnes PJ. Exhaled 8-isoprostane as an in vivo biomarker of lung oxidative stress in patients with COPD and healthy smokers. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1175-7.

Ganas K, Loukides S, Papatheodorou G, Panagou P, Kalogeropoulos N. Total nitrite/nitrate in expired breath condensate of patients with asthma. Respir Med. 2001 Aug;95(8):649-54.

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.

Berg JT, Deem S, Kerr ME, Swenson ER. Hemoglobin and red blood cells alter the response of expired nitric oxide to mechanical forces. Am J Physiol Heart Circ Physiol. 2000 Dec;279(6):H2947-53.

Francoeur C, Denis M. Nitric oxide and interleukin-8 as inflammatory components of cystic fibrosis. Inflammation. 1995 Oct;19(5):587-98.

Jang AS, Choi IS, Lee S, Seo JP, Yang SW, Park KO, Lee KY, Lee JU, Park CS, Park HS. Nitric oxide metabolites in induced sputum: a marker of airway inflammation in asthmatic subjects. Clin Exp Allergy. 1999 Aug;29(8):1136-42.

Edwards YS, Sutherland LM, Murray AW. NO protects alveolar type II cells from stretch-induced apoptosis. A novel role for macrophages in the lung. Am J Physiol Lung Cell Mol Physiol. 2000 Dec;279(6):L1236-42.

Gessner C, Hammerschmidt S, Kuhn H, Lange T, Engelmann L, Schauer J, Wirtz H. Exhaled breath condensate nitrite and its relation to tidal volume in acute lung injury. Chest. 2003 Sep;124(3):1046-52.

Carpagnano GE, Kharitonov SA, Resta O, Foschino-Barbaro MP, Gramiccioni E, Barnes PJ. Increased 8-isoprostane and interleukin-6 in breath condensate of obstructive sleep apnea patients. Chest. 2002 Oct;122(4):1162-7.

Sack U, Scheibe R, Wötzel M, Hammerschmidt S, Kuhn H, Emmrich F, Hoheisel G, Wirtz H, Gessner C. Multiplex analysis of cytokines in exhaled breath condensate. Cytometry A. 2006 Mar;69(3):169-72.

Wrigge H, Uhlig U, Zinserling J, Behrends-Callsen E, Ottersbach G, Fischer M, Uhlig S, Putensen C. The effects of different ventilatory settings on pulmonary and systemic inflammatory responses during major surgery. Anesth Analg. 2004 Mar;98(3):775-81, table of contents.

Wrigge H, Zinserling J, Stüber F, von Spiegel T, Hering R, Wetegrove S, Hoeft A, Putensen C. Effects of mechanical ventilation on release of cytokines into systemic circulation in patients with normal pulmonary function. Anesthesiology. 2000 Dec;93(6):1413-7.

Koner O, Celebi S, Balci H, Cetin G, Karaoglu K, Cakar N. Effects of protective and conventional mechanical ventilation on pulmonary function and systemic cytokine release after cardiopulmonary bypass. Intensive Care Med. 2004 Apr;30(4):620-6. Epub 2004 Jan 13.

Bonetto C, Terragni P, Ranieri VM. Does high tidal volume generate ALI/ARDS in healthy lungs? Intensive Care Med. 2005 Jul;31(7):893-5. Epub 2005 Jun 2. No abstract available.

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:	Zakynthinos E, Intensive Care Unit department University Hospital Larissa
ClinicalTrials.gov Identifier:	NCT00910026 History of Changes
Other Study ID Numbers:	4163/02-09-2008
Study First Received:	May 28, 2009
Last Updated:	November 2, 2009
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 May 16, 2013

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