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

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT00188058
Collaborator
Ministry of Health, France (Other)
768
Enrollment
47
Locations
2
Arms
41
Actual Duration (Months)
16.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Setting of positive end-expiratory pressure
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
768 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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).
Actual Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Feb 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mortality at 28 days [day 28]

Secondary Outcome Measures

  1. Mortality at 60 days [day 60]

  2. In hospital mortality [day 60]

  3. Ventilator free Days through day 28 [day 28]

  4. Number of new organ failure before day 28 [day 28]

  5. Proportion of patients alive and unassisted breathing at 28 days [day 28]

  6. Number of patients with pneumothorax [day 28]

  7. Number of days alive between the first positive "potential weanability test" and day 28 [day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 General Hospital of Aix en Provence Aix en Provence France 13616
2 South Hospital of Amiens Amiens France 80054
3 University Hospital of Amiens Amiens France 80054
4 University Hospital of Angers Angers France 49033
5 University Hospital of Angers Angers France 49933
6 Victor Dupouy Hospital Argenteuil France 95107
7 General Hospital of Arras Arras France 62022
8 Robert Ballanger Hospital Aulnay Sous Bois France 93602
9 General Hospital of Avignon Avignon France 84902
10 Hospital of Beauvais Beauvais France 60021
11 Saint André Hospital Bordeaux France 33075
12 University Hospital of Bordeaux Bordeaux France 33076
13 Cavale Blanche Hospital Brest France 29609
14 Hospital of Brive Brive France 19312
15 Henri Mondor Hospital Creteil France 94010
16 Henri Mondor Hospital Créteil France 94010
17 Hospital of Dax Dax France 40107
18 Hospital of Dieppe Dieppe France 76202
19 Departemental Hospital La Roche Sur Yon France 85025
20 Jacques Monod Hospital Le Havre France 76083
21 Le Kremlin Bicetre Hospital Le Kremlin Bicetre France 94275
22 Docteur Schaffner Hospital Lens France 62307
23 University Hospital of Claude Huriez Lille France 59037
24 Croix Rousse Hospital Lyon France 69317
25 Bon Secours Hospital Metz France 57038
26 Saint Eloi Hospital Montpellier France 34295
27 Hospital of Nancy Nancy France 54035
28 University Hospital of Hotel Dieu Nantes France 44093
29 University Hospital of Nimes Nimes France 30000
30 University Hospital of Nimes Nimes France 30029
31 Oloron Sainte Marie Hospital Oloron Sainte Marie France 64404
32 Regional Hospital of Orleans Orleans France 45067
33 Bichat Claude Bernard Hospital Paris France 75018
34 University Hospital of Hôtel Dieu Paris France 75181
35 Hospital Group of Pitié - Salpêtrière Paris France 75651
36 Hospital group of Pitié-Salpêtrière Paris France 75651
37 European Hospital of Georges Pompidou Paris France 75908
38 University Hospital of Jean Bernard Poitiers France 86021
39 University Hospital of La Milètrie Poitiers France 86021
40 René Dubos Hospital Pontoise France 95303
41 Charles Nicolle Hospital Rouen France 76031
42 University Hospital of Rouen Rouen France 76031
43 Saint Aubin Les Elbeuf Hospital Saint Aubin Les Elbeuf France 76500
44 University Hospital of Bellevue Saint-etienne France 42055
45 Hospital of Soissons Soissons France 02209
46 Hautepierre Hospital Strasbourg France 67098
47 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00188058
Other Study ID Numbers:
  • PHRC 01 - 02
  • DGS : 2002 - 0381
First Posted:
Sep 16, 2005
Last Update Posted:
Mar 22, 2019
Last Verified:
Mar 1, 2019
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:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Syndrome

Study Results

No Results Posted as of Mar 22, 2019