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

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Lung Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Setting of positive end-expiratory pressure
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, Positive end-expiratory pressure, Acute lung injury, Mechanical ventilation, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Aix en Provence
  • South Hospital of Amiens
  • University Hospital of Amiens
  • University Hospital of Angers
  • University Hospital of Angers
  • Victor Dupouy Hospital
  • General Hospital of Arras
  • Robert Ballanger Hospital
  • General Hospital of Avignon
  • Hospital of Beauvais
  • Saint André Hospital
  • University Hospital of Bordeaux
  • Cavale Blanche Hospital
  • Hospital of Brive
  • Henri Mondor Hospital
  • Henri Mondor Hospital
  • Hospital of Dax
  • Hospital of Dieppe
  • Departemental Hospital
  • Jacques Monod Hospital
  • Le Kremlin Bicetre Hospital
  • Docteur Schaffner Hospital
  • University Hospital of Claude Huriez
  • Croix Rousse Hospital
  • Bon Secours Hospital
  • Saint Eloi Hospital
  • Hospital of Nancy
  • University Hospital of Hotel Dieu
  • University Hospital of Nimes
  • University Hospital of Nimes
  • Oloron Sainte Marie Hospital
  • Regional Hospital of Orleans
  • Bichat Claude Bernard Hospital
  • University Hospital of Hôtel Dieu
  • Hospital Group of Pitié - Salpêtrière
  • Hospital group of Pitié-Salpêtrière
  • European Hospital of Georges Pompidou
  • University Hospital of Jean Bernard
  • University Hospital of La Milètrie
  • René Dubos Hospital
  • Charles Nicolle Hospital
  • University Hospital of Rouen
  • Saint Aubin Les Elbeuf Hospital
  • University Hospital of Bellevue
  • Hospital of Soissons
  • Hautepierre Hospital
  • Gustave Dron Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Minimal alveolar distension

Maximal alveolar distension

Arm Description

PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O

PEEP is set for a plateau pressure between 28 and 30 cm H20

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
March 20, 2019
Sponsor
University Hospital, Angers
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00188058
Brief Title
Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Acronym
ExPress
Official Title
Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2002 (Actual)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Lung Injury
Keywords
Acute respiratory distress syndrome, Positive end-expiratory pressure, Acute lung injury, Mechanical ventilation, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
768 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal alveolar distension
Arm Type
Active Comparator
Arm Description
PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O
Arm Title
Maximal alveolar distension
Arm Type
Experimental
Arm Description
PEEP is set for a plateau pressure between 28 and 30 cm H20
Intervention Type
Device
Intervention Name(s)
Setting of positive end-expiratory pressure
Primary Outcome Measure Information:
Title
Mortality at 28 days
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Mortality at 60 days
Time Frame
day 60
Title
In hospital mortality
Time Frame
day 60
Title
Ventilator free Days through day 28
Time Frame
day 28
Title
Number of new organ failure before day 28
Time Frame
day 28
Title
Proportion of patients alive and unassisted breathing at 28 days
Time Frame
day 28
Title
Number of patients with pneumothorax
Time Frame
day 28
Title
Number of days alive between the first positive "potential weanability test" and day 28
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALAIN MERCAT, MD
Organizational Affiliation
University Hospital of Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Aix en Provence
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
South Hospital of Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
University Hospital of Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Victor Dupouy Hospital
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
General Hospital of Arras
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
Robert Ballanger Hospital
City
Aulnay Sous Bois
ZIP/Postal Code
93602
Country
France
Facility Name
General Hospital of Avignon
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Hospital of Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Saint André Hospital
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
University Hospital of Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Cavale Blanche Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hospital of Brive
City
Brive
ZIP/Postal Code
19312
Country
France
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Henri Mondor Hospital
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hospital of Dax
City
Dax
ZIP/Postal Code
40107
Country
France
Facility Name
Hospital of Dieppe
City
Dieppe
ZIP/Postal Code
76202
Country
France
Facility Name
Departemental Hospital
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Jacques Monod Hospital
City
Le Havre
ZIP/Postal Code
76083
Country
France
Facility Name
Le Kremlin Bicetre Hospital
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Docteur Schaffner Hospital
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
University Hospital of Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Croix Rousse Hospital
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Bon Secours Hospital
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Saint Eloi Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hospital of Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
University Hospital of Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital of Nimes
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
University Hospital of Nimes
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Oloron Sainte Marie Hospital
City
Oloron Sainte Marie
ZIP/Postal Code
64404
Country
France
Facility Name
Regional Hospital of Orleans
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Bichat Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
University Hospital of Hôtel Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hospital Group of Pitié - Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hospital group of Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
European Hospital of Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
University Hospital of Jean Bernard
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
University Hospital of La Milètrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
René Dubos Hospital
City
Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Charles Nicolle Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
University Hospital of Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Saint Aubin Les Elbeuf Hospital
City
Saint Aubin Les Elbeuf
ZIP/Postal Code
76500
Country
France
Facility Name
University Hospital of Bellevue
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hospital of Soissons
City
Soissons
ZIP/Postal Code
02209
Country
France
Facility Name
Hautepierre Hospital
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Gustave Dron Hospital
City
Tourcoing
ZIP/Postal Code
59208
Country
France

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
PubMed Identifier
23571515
Citation
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.
Results Reference
derived
PubMed Identifier
18270353
Citation
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.
Results Reference
derived

Learn more about this trial

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

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