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| Descriptive Information Fields | |||||
| Brief Title † | Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome | ||||
| Official Title † | Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study). | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Mortality at 28 days | ||||
| Secondary Outcome Measure † | Mortality at 60 days In hospital mortality Ventilator free Days through day 28 Number of new organ failure before day 28 Proportion of patients alive and unassisted breathing at 28 days Number of patients with pneumothorax Number of days alive between the first positive "potential weanability test" and day 28 |
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| Condition † | Acute Respiratory Distress Syndrome Acute Lung Injury |
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| Intervention † | Device: Setting of positive end-expiratory pressure | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 800 | ||||
| Start Date † | September 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | France | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00188058 | ||||
| Organization ID | PHRC 01 - 02 | ||||
| Secondary IDs †† | DGS : 2002 - 0381 | ||||
| Study Sponsor † | University Hospital, Angers | ||||
| Collaborators †† | Ministry of Health, France | ||||
| Investigators † |
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| Information Provided By | University Hospital, Angers | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||