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.
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Conditions
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
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
Primary outcomes
-
Mortality at 28 days
Time frame: day 28
Secondary outcomes
-
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
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.
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