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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Hospital, Angers.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Ministry of Health, France

Information provided by:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT00188058

First received: September 12, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

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).

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Heinz Body Anemias Respiratory Distress Syndrome, Infant

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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, 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
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: 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
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

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 ClinicalTrials.gov Identifier (NCT Number):

Diehl JL, Coolen N, Faisy C, Osman D, Prat G, Sebbane M, Nieszkowska A, Gervais C, Richard JC, Richecoeur J, Brochard L, Mercat A, Guérot 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.

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.


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

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:


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

ClinicalTrials.gov processed this record on March 03, 2015

To Top