Skip to main content
OpenTrials
Completed

NCT Number: NCT00188058

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Aix en Provence, Aix-en-Provence, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Setting of positive end-expiratory pressure

Device

Primary outcomes

  1. Mortality at 28 days

    Time frame: day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: ExPress

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.