Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ExPress)
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ClinicalTrials.gov Identifier: NCT00188058 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : March 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Distress Syndrome Acute Lung Injury | Device: Setting of positive end-expiratory pressure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 768 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study). |
Actual Study Start Date : | September 2002 |
Actual Primary Completion Date : | January 2006 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Minimal alveolar distension
PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O
|
Device: Setting of positive end-expiratory pressure |
Experimental: Maximal alveolar distension
PEEP is set for a plateau pressure between 28 and 30 cm H20
|
Device: Setting of positive end-expiratory pressure |
- Mortality at 28 days [ Time Frame: day 28 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188058

Principal Investigator: | ALAIN MERCAT, MD | University Hospital of Angers |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Angers |
ClinicalTrials.gov Identifier: | NCT00188058 |
Other Study ID Numbers: |
PHRC 01 - 02 DGS : 2002 - 0381 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | March 22, 2019 |
Last Verified: | March 2019 |
Acute respiratory distress syndrome Positive end-expiratory pressure Acute lung injury Mechanical ventilation Randomized controlled trial |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Lung Injury Syndrome Disease Pathologic Processes |
Wounds and Injuries Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries |