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

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ClinicalTrials.gov Identifier: NCT00188058
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Angers

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Acute Lung Injury Device: Setting of positive end-expiratory pressure Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
Study Start Date : September 2002

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Mortality at 28 days

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188058


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

Locations
France
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
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 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         
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         
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         
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         
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         
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         
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         
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         
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 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         
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         
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         
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         
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         
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         
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         
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         
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         
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         
Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France
Investigators
Principal Investigator: ALAIN MERCAT, MD University Hospital of Angers
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00188058     History of Changes
Other Study ID Numbers: PHRC 01 - 02
DGS : 2002 - 0381
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

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:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries