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

March 20, 2019 updated by: University Hospital, Angers

Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

768

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Minimal alveolar distension
PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O
Device: Setting of positive end-expiratory pressure
Experimental: Maximal alveolar distension
PEEP is set for a plateau pressure between 28 and 30 cm H20
Device: Setting of positive end-expiratory pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality at 28 days
Time Frame: day 28
day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality at 60 days
Time Frame: day 60
day 60
In hospital mortality
Time Frame: day 60
day 60
Ventilator free Days through day 28
Time Frame: day 28
day 28
Number of new organ failure before day 28
Time Frame: day 28
day 28
Proportion of patients alive and unassisted breathing at 28 days
Time Frame: day 28
day 28
Number of patients with pneumothorax
Time Frame: day 28
day 28
Number of days alive between the first positive "potential weanability test" and day 28
Time Frame: day 28
day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: ALAIN MERCAT, MD, University Hospital of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 01 - 02
  • DGS : 2002 - 0381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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