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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2006

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.

Interventions

  • Device: Setting of positive end-expiratory pressure

Arms, Groups and Cohorts

  • Active Comparator: Minimal alveolar distension
    • PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O
  • Experimental: Maximal alveolar distension
    • PEEP is set for a plateau pressure between 28 and 30 cm H20

Clinical Trial Outcome Measures

Primary Measures

  • Mortality at 28 days
    • Time Frame: day 28

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Angers
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ALAIN MERCAT, MD, Principal Investigator, University Hospital of Angers

Citations Reporting on 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

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