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

University Hospital, Angers

Status

Completed

Conditions

Acute Lung Injury

Acute Respiratory Distress Syndrome

Treatments

Device: Setting of positive end-expiratory pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT00188058

DGS : 2002 - 0381

PHRC 01 - 02

Details and patient eligibility

About

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 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.

Enrollment

768 patients

Sex

All

Ages

18+ years old

Volunteers

No 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