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

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ClinicalTrials.gov Identifier: NCT00188058
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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
Acute Respiratory Distress Syndrome Acute Lung Injury Device: Setting of positive end-expiratory pressure Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : September 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : February 2006

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mortality at 28 days [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. Mortality at 60 days [ Time Frame: day 60 ]
  2. In hospital mortality [ Time Frame: day 60 ]
  3. Ventilator free Days through day 28 [ Time Frame: day 28 ]
  4. Number of new organ failure before day 28 [ Time Frame: day 28 ]
  5. Proportion of patients alive and unassisted breathing at 28 days [ Time Frame: day 28 ]
  6. Number of patients with pneumothorax [ Time Frame: day 28 ]
  7. Number of days alive between the first positive "potential weanability test" and day 28 [ Time Frame: day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188058


Locations
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Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France
Investigators
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Principal Investigator: ALAIN MERCAT, MD University Hospital of Angers
More Information
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Publications of Results:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00188058    
Other Study ID Numbers: PHRC 01 - 02
DGS : 2002 - 0381
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 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:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Syndrome
Disease
Pathologic Processes
 Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries