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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury

• Registration Number: NCT00188058
• Lead Sponsor: University Hospital, Angers

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.

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2006-01
• Study Completion: 2006-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 768

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality at 28 days	day 28

Secondary Outcome Measures

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

Trial Locations

Locations (44)

General Hospital of Aix en Provence; 🇫🇷 Aix en Provence, France

South Hospital of Amiens; 🇫🇷 Amiens, France

University Hospital of Amiens; 🇫🇷 Amiens, France

University Hospital of Angers; 🇫🇷 Angers, France

Victor Dupouy Hospital; 🇫🇷 Argenteuil, France

General Hospital of Arras; 🇫🇷 Arras, France

Robert Ballanger Hospital; 🇫🇷 Aulnay Sous Bois, France

General Hospital of Avignon; 🇫🇷 Avignon, France

Hospital of Beauvais; 🇫🇷 Beauvais, France

Saint André Hospital; 🇫🇷 Bordeaux, France

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