Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
ExPress
Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
2 other identifiers
interventional
768
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2002
Longer than P75 for not_applicable
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedMarch 22, 2019
March 1, 2019
3.3 years
September 12, 2005
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality at 28 days
day 28
Secondary Outcomes (7)
Mortality at 60 days
day 60
In hospital mortality
day 60
Ventilator free Days through day 28
day 28
Number of new organ failure before day 28
day 28
Proportion of patients alive and unassisted breathing at 28 days
day 28
- +2 more secondary outcomes
Study Arms (2)
Minimal alveolar distension
ACTIVE COMPARATORPEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O
Maximal alveolar distension
EXPERIMENTALPEEP is set for a plateau pressure between 28 and 30 cm H20
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Angerslead
- Ministry of Health, Francecollaborator
Study Sites (46)
General Hospital of Aix en Provence
Aix-en-Provence, 13616, France
South Hospital of Amiens
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
Related Publications (3)
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
RESULTDiehl 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.
PMID: 23571515DERIVEDMercat 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.
PMID: 18270353DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ALAIN MERCAT, MD
University Hospital of Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
September 1, 2002
Primary Completion
January 1, 2006
Study Completion
February 1, 2006
Last Updated
March 22, 2019
Record last verified: 2019-03