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Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

This study is currently recruiting participants.
Verified by University Hospital, Angers, September 2005

Sponsors and Collaborators: University Hospital, Angers
Ministry of Health, France
Information provided by: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00188058
  Purpose

The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.


Condition Intervention
Acute Respiratory Distress Syndrome
Acute Lung Injury
 Device: Setting of positive end-expiratory pressure

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Mortality at 28 days

Secondary Outcome Measures:
  • Mortality at 60 days
  • In hospital mortality
  • Ventilator free Days through day 28
  • Number of new organ failure before day 28
  • Proportion of patients alive and unassisted breathing at 28 days
  • Number of patients with pneumothorax
  • Number of days alive between the first positive "potential weanability test" and day 28

Estimated Enrollment:   800
Study Start Date:   September 2002

Detailed Description:

Most patients suffering from acute lung injury or acute respiratory distress syndrome require mechanical ventilation. In this setting, positive end-expiratory pressure is used to improve arterial oxygenation. While the beneficial effect on clinical outcome of using low tidal volume is clearly proven, the best way to titrate PEEP is not known. Higher PEEP levels may better improve oxygenation and reduce ventilator-induced lung injury by reducing end-expiratory alveolar collapse but may also cause circulatory depression and aggravate lung injury from end-inspiratory overdistension. This trial compares the impact on outcome of two strategies for setting PEEP. In the "minimal alveolar distension" arm, PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H20). In the "maximal alveolar recruitment" arm, PEEP is set for a plateau pressure between 28 and 30 cm H20. A tidal volume of 6 ml/kg predicted body weight is used in the two arms. The goals for arterial oxygenation and PaCO2 are the same in the two arms.

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

Criteria

Inclusion Criteria:

  • Mechanical ventilation through an endotracheal tube
  • Bilateral infiltrates consistent with pulmonary edema
  • PaO2/FiO2 < 300 mmHg
  • No clinical evidence of left atrial hypertension. If measured, pulmonary artery occlusion pressure < 18 mmHg
  • Criteria 1, 2 et 3 jointly present for less than 48 hours
  • Written informed consent obtained from the patient or surrogate

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Expected duration of mechanical ventilation through an endotracheal tube < 48 hours
  • Participation in other trials within the previous 30 days
  • Increased intracranial pressure
  • Severe chronic respiratory disease
  • Morbid obesity (weight > 1kg/cm)
  • Sickle cell disease
  • Bone marrow transplant or chemotherapy-induced neutropenia
  • Extended burns (> 30 % total body surface area)
  • Severe chronic liver disease (Child-Pugh score C)
  • Pneumothorax
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188058

Contacts
Contact: ALAIN MERCAT, MD     (0)2–41–35–38–15 ext 33     AlMercat@chu-angers.fr    

Locations
France
University Hospital of Angers     Recruiting
      Angers, France, 49933
      Contact: ALAIN MERCAT, MD     (0)2 - 41 - 35 - 38 - 15 ext 33     AlMercat@chu-angers.fr    
      Principal Investigator: ALAIN MERCAT, MD            
      Sub-Investigator: ACHILLE KOUATCHET, MD            
University Hospital of Rouen     Recruiting
      Rouen, France, 76031
      Contact: JEAN-CHRISTOPHE RICHARD, MD     (0)2 32 88 82 61 ext 33     jrichard@invivo.edu    
      Principal Investigator: JEAN-CHRISTOPHE RICHARD, MD            
      Sub-Investigator: BOUCHRA LAMIA, MD            
Henri Mondor Hospital     Recruiting
      Creteil, France, 94010
      Contact: LAURENT BROCHARD, MD     (0)1 49 81 23 96 ext 33     laurent.brochard@hmn.ap-hop-paris.fr    
      Principal Investigator: LAURENT BROCHARD, MD            
      Sub-Investigator: ANTONIO ALVAREZ, MD            
      Sub-Investigator: ARNAUD THILLE, MD            
Hospital group of Pitié-Salpêtrière     Recruiting
      Paris, France, 75651
      Contact: ALEXANDRE DUGUET, MD     (0)1 42 17 67 61 ext 33     alexandre.duguet@psl.ap-hop-paris.fr    
      Principal Investigator: ALEXANDRE DUGUET, MD            
      Sub-Investigator: ALEXANDRE DEMOULE, MD            
European Hospital of Georges Pompidou     Recruiting
      Paris, France, 75908
      Contact: JEAN-LUC DIEHL, MD     (0)1 56 09 32 01 ext 33     jldiehl@invivo.edu    
      Principal Investigator: JEAN-LUC DIEHL, MD            
University Hospital of Bellevue     Not yet recruiting
      Saint-Etienne, France, 42055
      Contact: FABRICE ZENI, MD     (0)4 77 12 78 62 ext 33     zeni@univ-st-etienne.fr    
      Principal Investigator: FABRICE ZENI, MD            
Hautepierre Hospital     Recruiting
      Strasbourg, France, 67098
      Contact: FRANCIS SCHNEIDER, MD     (0)3 88 12 79 06 ext 33     Francis.Schneider@chru-strasbourg.fr    
      Principal Investigator: FRANCIS SCHNEIDER, MD            
      Sub-Investigator: VINCENT CASTELAIN, MD            
      Sub-Investigator: FERHAT MEZIANI, MD            
Regional Hospital of Orleans     Recruiting
      Orleans, France, 45067
      Contact: THIERRY BOULAIN, MD     (0)2 38 51 44 46 ext 33     thierryboulain@chr-orleans.fr    
      Principal Investigator: THIERRY BOULAIN, MD            
Hospital Group of Pitié - Salpêtrière     Recruiting
      Paris, France, 75651
      Contact: JEAN CHASTRE, MD     (0)1 42 16 38 21 ext 33     jean.chastre@psl.ap-hop-paris.fr    
      Principal Investigator: JEAN CHASTRE, MD            
      Sub-Investigator: ANIA NIESZKOWSKA, MD            
Departemental Hospital     Recruiting
      La Roche-sur-Yon, France, 85025
      Contact: EVA CLEMENTI, MD     (0)2 51 44 62 12 ext 33     evclemen@free.fr    
      Principal Investigator: EVA CLEMENTI, MD            
Hospital of Brive     Recruiting
      Brive, France, 19312
      Contact: ELIAS KARAM, MD     (0)5 55 92 60 13 ext 33     reanimation@ch-brive.fr    
      Principal Investigator: ELIAS KARAM, MD            
University Hospital of Hotel Dieu     Recruiting
      Nantes, France, 44093
      Contact: CHRISTOPHE GUITTON, MD     (0)2 40 08 73 65     christophe.guitton@chu-nantes.fr    
      Principal Investigator: CHRISTOPHE GUITTON, MD            
Hospital of Nancy     Not yet recruiting
      Nancy, France, 54035
      Contact: AURELIE CRAVOISY, MD     (0)3 83 85 14 94 ext 33     a.cravoisy@wanadoo.fr    
      Principal Investigator: AURELIE CRAVOISY, MD            
University Hospital of Nimes     Recruiting
      Nimes, France, 30029
      Contact: CLAUDE GERVAIS, MD     (0)4 66 68 33 20 ext 33     claude.gervais@ chu-nimes.fr    
      Principal Investigator: CLAUDE GERVAIS, MD            
      Sub-Investigator: CHARLES ARICH, MD            
      Sub-Investigator: CHRISTIAN BENGLER, MD            
University Hospital of Angers     Recruiting
      Angers, France, 49033
      Contact: LAURENT BEYDON, MD     (0)2 41 35 39 51 ext 33     lbeydon.angers@invivo.edu    
      Principal Investigator: LAURENT BEYDON, MD            
Hospital of Dax     Not yet recruiting
      Dax, France, 40107
      Contact: THIERRY MAYET, MD     (0)5 58 91 49 51 ext 33     SAINT-PAULV@ch-dax.fr    
      Principal Investigator: THIERRY MAYET, MD            
Croix Rousse Hospital     Recruiting
      Lyon, France, 69317
      Contact: CLAUDE GUERIN, MD     (0)4 72 07 17 62 ext 33     claude.guerin@chu-lyon.fr    
      Principal Investigator: CLAUDE GUERIN, MD            
      Sub-Investigator: MICHEL BADET, MD            
Saint André Hospital     Recruiting
      Bordeaux, France, 33075
      Contact: OLIVIER GUISSET, MD     (0)5 56 79 55 30 ext 33     olivier.guisset@chu-bordeaux.fr    
      Principal Investigator: OLIVIER GUISSET, MD            
René Dubos Hospital     Recruiting
      Pontoise, France, 95303
      Contact: JACK RICHECOEUR, MD     (0)1 30 75 43 37 ext 33     richecoeur@ch-pontoise.fr    
      Principal Investigator: JACK RICHECOEUR, MD            
Hospital of Dieppe     Not yet recruiting
      Dieppe, France, 76202
      Contact: MICHEL PINSARD, MD     (0)2 32 14 75 50 ext 33     mpinsard@ch-dieppe.fr    
      Principal Investigator: MICHEL PINSARD, MD            
Saint Aubin Les Elbeuf Hospital     Recruiting
      Saint-Aubin-les-Elbeuf, France, 76500
      Contact: OLIVIER DELASTRE, MD     (0)2 32 96 35 32 ext 33     delastreo@chi.elbeuf-louviers.rss.fr    
      Principal Investigator: OLIVIER DELASTRE, MD            
Robert Ballanger Hospital     Not yet recruiting
      Aulnay-sous-Bois, France, 93602
      Contact: BRUNO MOURVILLIER, MD     (0)1 49 36 71 91 ext 33     bruno.mourvillier@ch-aulnay.fr    
      Principal Investigator: BRUNO MOURVILLIER, MD            
University Hospital of Amiens     Not yet recruiting
      Amiens, France, 80054
      Contact: MICHEL OSSART, MD     (0)3 22 66 83 80 ext 33     ossart.michel@chu-amiens.fr    
      Principal Investigator: MICHEL OSSART, MD            
General Hospital of Avignon     Recruiting
      Avignon, France, 84902
      Contact: JEROME BAUDOT, MD     (0)4 32 75 34 61 ext 33     jbaudot@club-internet.fr    
      Principal Investigator: JEROME BAUDOT, MD            
Oloron Sainte Marie Hospital     Recruiting
      Oloron-Sainte-Marie, France, 64404
      Contact: JEAN-MARC MAZOU, MD     (0)5 59 88 30 30 ext 33     jm.mazou@choloron.aquisante.fr    
      Principal Investigator: JEAN-MARC MAZOU, MD            
University Hospital of Nimes     Recruiting
      Nimes, France, 30000
      Contact: JEAN-YVES LEFRANT, MD     (0)4 66 68 33 31 ext 33     jean.yves.lefrant@chu-nimes.fr    
      Principal Investigator: JEAN-YVES LEFRANT, MD            
      Sub-Investigator: LAURENT MULLER, MD            
Henri Mondor Hospital     Not yet recruiting
      Créteil, France, 94010
      Contact: FRANCOIS DECAILLIOT, MD     (0)1 49 81 23 43 ext 33     francois.decailliot@hmn.ap-hop-paris.fr    
      Principal Investigator: FRANCOIS DECAILLIOT, MD            
Victor Dupouy Hospital     Recruiting
      Argenteuil, France, 95107
      Contact: JEAN-PIERRE SOLLET, MD     (0)1 34 23 24 51 ext 33     jps@fc.horus-medical.fr    
      Principal Investigator: JEAN-PIERRE SOLLET, MD            
Le Kremlin Bicetre Hospital     Recruiting
      Le Kremlin-Bicetre, France, 94275
      Contact: CHRISTIAN RICHARD, MD     (0)1 45 21 35 44 ext 33     christian.richard@bct.ap-hop-paris.fr    
      Principal Investigator: CHRISTIAN RICHARD, MD            
      Sub-Investigator: DAVID OSMAN, MD            
Bon Secours Hospital     Recruiting
      Metz, France, 57038
      Contact: THIERRY JACQUES, MD     (0)3 87 55 35 66 ext 33     jacquestf@free.fr    
      Principal Investigator: THIERRY JACQUES, MD            
University Hospital of Bordeaux     Recruiting
      Bordeaux, France, 33076
      Contact: GILLES HILBERT, MD     (0)5 56 79 98 29 ext 33     gilles.hilbert@chu-bordeaux.fr    
      Principal Investigator: GILLES HILBERT, MD            
Cavale Blanche Hospital     Recruiting
      Brest, France, 29609
      Contact: ERWAN L'HER, MD     (0)2 98 34 71 81 ext 33     elher@univ-brest.fr    
      Principal Investigator: ERWAN L'HER, MD            
      Sub-Investigator: GWENAEL PRAT, MD            
General Hospital of Aix en Provence     Recruiting
      Aix-en-Provence, France, 13616
      Contact: LUC RODRIGUEZ, MD     (0)4 42 33 50 24 ext 33     lrodriguez@ch-aix.fr    
      Principal Investigator: LUC RODRIGUEZ, MD            
Gustave Dron Hospital     Not yet recruiting
      Tourcoing, France, 59208
      Contact: BENOIT GUERY, MD     (0)3 20 69 44 30 ext 33     bguery@invivo.com    
      Principal Investigator: BENOIT GUERY, MD            
University Hospital of La Milètrie     Recruiting
      Poitiers, France, 86021
      Contact: OLIVIER MIMOZ, MD     (0)5 49 44 42 30 ext 33     o.mimoz@chu-poitiers.fr    
      Principal Investigator: OLIVIER MIMOZ, MD            
      Sub-Investigator: FATIMA RAYEH, MD            
University Hospital of Jean Bernard     Recruiting
      Poitiers, France, 86021
      Contact: JEAN-PIERRE FRAT, MD     (0)5 49 44 43 67 ext 33     jpfrat@chu-poitiers.fr    
      Principal Investigator: JEAN-PIERRE FRAT, MD            
Saint Eloi Hospital     Recruiting
      Montpellier, France, 34295
      Contact: SAMIR JABER, MD     (0)4 67 33 72 71 ext 33     jaber@in3.inserm.fr    
      Principal Investigator: SAMIR JABER, MD            
      Sub-Investigator: MUSTAPHA SEBBANE, MD            
University Hospital of Hôtel Dieu     Recruiting
      Paris, France, 75181
      Contact: ANTOINE RABBAT, MD     (0)1 42 34 86 37 ext 33     antoine.rabbat@htd.ap-hop-paris.fr    
      Principal Investigator: ANTOINE RABBAT, MD            
Charles Nicolle Hospital     Recruiting
      Rouen, France, 76031
      Contact: CEDRIC DAMM, MD     (0)2 32 88 82 92 ext 33     cedric.damm@chu-rouen.fr    
      Sub-Investigator: CEDRIC DAMM, MD            
      Principal Investigator: BENOIT VEBER, MD            
      Sub-Investigator: OLIVIER COLLANGE, MD            
Jacques Monod Hospital     Not yet recruiting
      Le Havre, France, 76083
      Contact: JEAN NOUVEAU, MD     (0)2 32 73 31 90 ext 33     jnouveau@ch-havre.fr    
      Principal Investigator: JEAN NOUVEAU, MD            
University Hospital of Amiens     Recruiting
      Amiens, France, 80054
      Contact: VINCENT JOUNIEAUX, MD     (0)3 22 45 59 05 ext 33     jounieaux.vincent@chu-amiens.fr    
      Principal Investigator: VINCENT JOUNIEAUX, MD            
Hospital of Soissons     Recruiting
      Soissons, France, 02209
      Contact: PIERRE-YVES LALLEMENT, MD     (0)3 23 70 74 34 ext 33     py.lallement@ch-soissons.fr    
      Principal Investigator: PIERRE-YVES LALLEMENT, MD            
Hospital of Beauvais     Not yet recruiting
      Beauvais, France, 60021
      Contact: ANNE-MARIE GUERIN, MD     (0)3 44 11 21 87 ext 33     am.guerin@ch-beauvais.fr    
      Principal Investigator: ANNE-MARIE GUERIN, MD            
University Hospital of Claude Huriez     Not yet recruiting
      Lille, France, 59037
      Contact: PIERRE-ANDRE RODIE TALBERE, MD     (0)3 20 44 41 80 ext 33     pa-rodietalbere@chru-lille.fr    
      Principal Investigator: PIERRE-ANDRE RODIE TALBERE, MD            
Docteur Schaffner Hospital     Recruiting
      Lens, France, 62307
      Contact: DIDIER THEVENIN, MD     (0)3 20 69 10 88 ext 33     dthevenin@ch-lens.fr    
      Principal Investigator: DIDIER THEVENIN, MD            
Bichat Claude Bernard Hospital     Recruiting
      Paris, France, 75018
      Contact: FREDERIQUE SCHORTGEN, MD     (0)1 40 25 77 03 ext 33     frederique.schortgen@bch.ap-hop-paris.fr    
      Principal Investigator: FREDERIQUE SCHORTGEN, MD            
      Sub-Investigator: LILA BOUADMA, MD            
General Hospital of Arras     Not yet recruiting
      Arras, France, 62022
      Contact: DIDIER DUBOIS, MD     (0)3 21 24 46 45 ext 33     didier.dubois@ch-arras.fr    
      Principal Investigator: DIDIER DUBOIS, MD            

Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France

Investigators
Principal Investigator:     ALAIN MERCAT, MD     University Hospital of Angers    
  More Information

Publications indexed to this study:
Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55.
 

Study ID Numbers:   PHRC 01 - 02, DGS : 2002 - 0381
First Received:   September 12, 2005
Last Updated:   September 12, 2005
ClinicalTrials.gov Identifier:   NCT00188058
Health Authority:   France: Ministry of Health

Keywords provided by University Hospital, Angers:
Acute respiratory distress syndrome  
Positive end-expiratory pressure  
Acute lung injury  
Mechanical ventilation  
Randomized controlled trial  

Study placed in the following topic categories:
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on August 28, 2008

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