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| 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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). |
| Estimated Enrollment: | 800 |
| Study Start Date: | September 2002 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: ALAIN MERCAT, MD | (0)2–41–35–38–15 ext 33 | AlMercat@chu-angers.fr |
| 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 | 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 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 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 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Principal Investigator: | ALAIN MERCAT, MD | University Hospital of Angers |
More Information
| ClinicalTrials.gov Identifier: | NCT00188058 History of Changes |
| Other Study ID Numbers: | PHRC 01 - 02, DGS : 2002 - 0381 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | France: Ministry of Health |
|
Acute respiratory distress syndrome Positive end-expiratory pressure Acute lung injury Mechanical ventilation Randomized controlled trial |
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
