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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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:


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   (Adult, Senior)
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

Locations
France
General Hospital of Aix en Provence
Aix-en-Provence, France, 13616
University Hospital of Amiens
Amiens, France, 80054
University Hospital of Angers
Angers, France, 49033
University Hospital of Angers
Angers, France, 49933
Victor Dupouy Hospital
Argenteuil, France, 95107
General Hospital of Arras
Arras, France, 62022
Robert Ballanger Hospital
Aulnay-sous-Bois, France, 93602
General Hospital of Avignon
Avignon, France, 84902
Hospital of Beauvais
Beauvais, France, 60021
Saint André Hospital
Bordeaux, France, 33075
University Hospital of Bordeaux
Bordeaux, France, 33076
Cavale Blanche Hospital
Brest, France, 29609
Hospital of Brive
Brive, France, 19312
Henri Mondor Hospital
Creteil, France, 94010
Henri Mondor Hospital
Créteil, France, 94010
Hospital of Dax
Dax, France, 40107
Hospital of Dieppe
Dieppe, France, 76202
Departemental Hospital
La Roche-sur-Yon, France, 85025
Jacques Monod Hospital
Le Havre, France, 76083
Le Kremlin Bicetre Hospital
Le Kremlin-Bicetre, France, 94275
Docteur Schaffner Hospital
Lens, France, 62307
University Hospital of Claude Huriez
Lille, France, 59037
Croix Rousse Hospital
Lyon, France, 69317
Bon Secours Hospital
Metz, France, 57038
Saint Eloi Hospital
Montpellier, France, 34295
Hospital of Nancy
Nancy, France, 54035
University Hospital of Hotel Dieu
Nantes, France, 44093
University Hospital of Nimes
Nimes, France, 30000
University Hospital of Nimes
Nimes, France, 30029
Oloron Sainte Marie Hospital
Oloron-Sainte-Marie, France, 64404
Regional Hospital of Orleans
Orleans, France, 45067
Bichat Claude Bernard Hospital
Paris, France, 75018
University Hospital of Hôtel Dieu
Paris, France, 75181
Hospital Group of Pitié - Salpêtrière
Paris, France, 75651
Hospital group of Pitié-Salpêtrière
Paris, France, 75651
European Hospital of Georges Pompidou
Paris, France, 75908
University Hospital of Jean Bernard
Poitiers, France, 86021
University Hospital of La Milètrie
Poitiers, France, 86021
René Dubos Hospital
Pontoise, France, 95303
Charles Nicolle Hospital
Rouen, France, 76031
University Hospital of Rouen
Rouen, France, 76031
Saint Aubin Les Elbeuf Hospital
Saint-Aubin-les-Elbeuf, France, 76500
University Hospital of Bellevue
Saint-Etienne, France, 42055
Hospital of Soissons
Soissons, France, 02209
Hautepierre Hospital
Strasbourg, France, 67098
Gustave Dron Hospital
Tourcoing, France, 59208
Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France
Investigators
Principal Investigator: ALAIN MERCAT, MD University Hospital of Angers
  More Information

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 
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:
Syndrome
Wounds and Injuries
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

ClinicalTrials.gov processed this record on December 05, 2016