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| ID | Type | Description | Link |
|---|---|---|---|
| DGS : 2002 - 0381 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal alveolar distension | Active Comparator | PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O |
|
| Maximal alveolar distension | Experimental | PEEP is set for a plateau pressure between 28 and 30 cm H20 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Setting of positive end-expiratory pressure | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 28 days | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 60 days | day 60 | |
| In hospital mortality | day 60 | |
| Ventilator free Days through day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALAIN MERCAT, MD | University Hospital of Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Aix en Provence | Aix-en-Provence | 13616 | France | |||
| South Hospital of Amiens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Mercat A, Richard J, Brochard L. Comparison of two strategies for setting Peep in ALI/ARDS : EsPress Study.Intensive care med, 19th ESICM Annual Congress - Barcelona, Spain, 2006 Sep, Oral presentation 0365 | ||
| 23571515 | Derived | Diehl JL, Coolen N, Faisy C, Osman D, Prat G, Sebbane M, Nieszkowska A, Gervais C, Richard JC, Richecoeur J, Brochard L, Mercat A, Guerot E, Borgel D. Growth-arrest-specific 6 (GAS6) protein in ARDS patients: determination of plasma levels and influence of PEEP setting. Respir Care. 2013 Nov;58(11):1886-91. doi: 10.4187/respcare.02129. Epub 2013 Apr 9. | |
| 18270353 |
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| day 28 |
| Number of new organ failure before day 28 | day 28 |
| Proportion of patients alive and unassisted breathing at 28 days | day 28 |
| Number of patients with pneumothorax | day 28 |
| Number of days alive between the first positive "potential weanability test" and day 28 | day 28 |
| Amiens |
| 80054 |
| France |
| University Hospital of Amiens | Amiens | 80054 | France |
| University Hospital of Angers | Angers | 49033 | France |
| University Hospital of Angers | Angers | 49933 | France |
| Victor Dupouy Hospital | Argenteuil | 95107 | France |
| General Hospital of Arras | Arras | 62022 | France |
| Robert Ballanger Hospital | Aulnay-sous-Bois | 93602 | France |
| General Hospital of Avignon | Avignon | 84902 | France |
| Hospital of Beauvais | Beauvais | 60021 | France |
| Saint André Hospital | Bordeaux | 33075 | France |
| University Hospital of Bordeaux | Bordeaux | 33076 | France |
| Cavale Blanche Hospital | Brest | 29609 | France |
| Hospital of Brive | Brivé | 19312 | France |
| Henri Mondor Hospital | Créteil | 94010 | France |
| Hospital of Dax | Dax | 40107 | France |
| Hospital of Dieppe | Dieppe | 76202 | France |
| Departemental Hospital | La Roche-sur-Yon | 85025 | France |
| Jacques Monod Hospital | Le Havre | 76083 | France |
| Le Kremlin Bicetre Hospital | Le Kremlin-Bicêtre | 94275 | France |
| Docteur Schaffner Hospital | Lens | 62307 | France |
| University Hospital of Claude Huriez | Lille | 59037 | France |
| Croix Rousse Hospital | Lyon | 69317 | France |
| Bon Secours Hospital | Metz | 57038 | France |
| Saint Eloi Hospital | Montpellier | 34295 | France |
| Hospital of Nancy | Nancy | 54035 | France |
| University Hospital of Hotel Dieu | Nantes | 44093 | France |
| University Hospital of Nimes | Nîmes | 30000 | France |
| University Hospital of Nimes | Nîmes | 30029 | France |
| Oloron Sainte Marie Hospital | Oloron-Sainte-Marie | 64404 | France |
| Regional Hospital of Orleans | Orléans | 45067 | France |
| Bichat Claude Bernard Hospital | Paris | 75018 | France |
| University Hospital of Hôtel Dieu | Paris | 75181 | France |
| Hospital Group of Pitié - Salpêtrière | Paris | 75651 | France |
| Hospital group of Pitié-Salpêtrière | Paris | 75651 | France |
| European Hospital of Georges Pompidou | Paris | 75908 | France |
| University Hospital of Jean Bernard | Poitiers | 86021 | France |
| University Hospital of La Milètrie | Poitiers | 86021 | France |
| René Dubos Hospital | Pontoise | 95303 | France |
| Charles Nicolle Hospital | Rouen | 76031 | France |
| University Hospital of Rouen | Rouen | 76031 | France |
| Saint Aubin Les Elbeuf Hospital | Saint-Aubin-lès-Elbeuf | 76500 | France |
| University Hospital of Bellevue | Saint-Etienne | 42055 | France |
| Hospital of Soissons | Soissons | 02209 | France |
| Hautepierre Hospital | Strasbourg | 67098 | France |
| Gustave Dron Hospital | Tourcoing | 59208 | France |
| Derived |
| 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. doi: 10.1001/jama.299.6.646. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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