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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
First Received: September 12, 2005   No Changes Posted
Sponsor: University Hospital, Angers
Collaborator: 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

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

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00188058     History of Changes
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

Additional relevant MeSH terms:
Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases
 Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on November 22, 2009



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