Acute Respiratory Distress SyndromeExPressNCT00188058
Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
A study testing Setting of positive end-expiratory pressure in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by University Hospital, Angers at 46 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Lung Injury
- What is being tested?
- Setting of positive end-expiratory pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- 46 sitesFrance
- Study dates
- Sep 2002to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
France46 sites
General Hospital of Aix en Provence
Aix-en-Provence, 13616
South Hospital of Amiens
Amiens, 80054
University Hospital of Amiens
Amiens, 80054
University Hospital of Angers
Angers, 49033
University Hospital of Angers
Angers, 49933
Victor Dupouy Hospital
Argenteuil, 95107
General Hospital of Arras
Arras, 62022
Robert Ballanger Hospital
Aulnay-sous-Bois, 93602
General Hospital of Avignon
Avignon, 84902
Hospital of Beauvais
Beauvais, 60021
Saint André Hospital
Bordeaux, 33075
University Hospital of Bordeaux
Bordeaux, 33076
Cavale Blanche Hospital
Brest, 29609
Hospital of Brive
Brivé, 19312
Henri Mondor Hospital
Créteil, 94010
Hospital of Dax
Dax, 40107
Hospital of Dieppe
Dieppe, 76202
Departemental Hospital
La Roche-sur-Yon, 85025
Jacques Monod Hospital
Le Havre, 76083
Le Kremlin Bicetre Hospital
Le Kremlin-Bicêtre, 94275
Docteur Schaffner Hospital
Lens, 62307
University Hospital of Claude Huriez
Lille, 59037
Croix Rousse Hospital
Lyon, 69317
Bon Secours Hospital
Metz, 57038
Saint Eloi Hospital
Montpellier, 34295
Hospital of Nancy
Nancy, 54035
University Hospital of Hotel Dieu
Nantes, 44093
University Hospital of Nimes
Nîmes, 30000
University Hospital of Nimes
Nîmes, 30029
Oloron Sainte Marie Hospital
Oloron-Sainte-Marie, 64404
Regional Hospital of Orleans
Orléans, 45067
Bichat Claude Bernard Hospital
Paris, 75018
University Hospital of Hôtel Dieu
Paris, 75181
Hospital Group of Pitié - Salpêtrière
Paris, 75651
Hospital group of Pitié-Salpêtrière
Paris, 75651
European Hospital of Georges Pompidou
Paris, 75908
University Hospital of Jean Bernard
Poitiers, 86021
University Hospital of La Milètrie
Poitiers, 86021
René Dubos Hospital
Pontoise, 95303
Charles Nicolle Hospital
Rouen, 76031
University Hospital of Rouen
Rouen, 76031
Saint Aubin Les Elbeuf Hospital
Saint-Aubin-lès-Elbeuf, 76500
University Hospital of Bellevue
Saint-Etienne, 42055
Hospital of Soissons
Soissons, 02209
Hautepierre Hospital
Strasbourg, 67098
Gustave Dron Hospital
Tourcoing, 59208
About this study
Official title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
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.
Read the 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.
- Being tested
- Setting of positive end-expiratory pressure
- Keywords
- Acute respiratory distress syndrome, Positive end-expiratory pressure, Acute lung injury, Mechanical ventilation, Randomized controlled trial
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setting of positive end-expiratory pressureDevice
| Study group | Role | What they receive |
|---|---|---|
| Minimal alveolar distension | Active comparator | PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O Receives: Device: Setting of positive end-expiratory pressure |
| Maximal alveolar distension | Experimental | PEEP is set for a plateau pressure between 28 and 30 cm H20 Receives: Device: Setting of positive end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 28 days
Measured: day 28
Secondary outcomes (7)
Mortality at 60 days
Measured: day 60
In hospital mortality
Measured: day 60
Ventilator free Days through day 28
Measured: day 28
Number of new organ failure before day 28
Measured: day 28
Proportion of patients alive and unassisted breathing at 28 days
Measured: day 28
Number of patients with pneumothorax
Measured: day 28
Number of days alive between the first positive "potential weanability test" and day 28
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionJan 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- ALAIN MERCAT, MD, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188058
- Sponsor's protocol ID
- PHRC 01 - 02
- Other IDs
- DGS : 2002 - 0381
- Acronym
- ExPress
- Status last verified
- Mar 2019
- First submitted
- 12 Sep 2005
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mercat A, Richard J, Brochard L. Comparison of two strategies for setting Peep in ALI/ARDS : EsPress Study.Intensive care med, 19th ESICM Annual Congress - Barcelona, Spain, 2006 Sep, Oral presentation 0365
Diehl JL, Coolen N, Faisy C, Osman D, Prat G, Sebbane M, Nieszkowska A, Gervais C, Richard JC, Richecoeur J, Brochard L, Mercat A, Guerot E, Borgel D. Growth-arrest-specific 6 (GAS6) protein in ARDS patients: determination of plasma levels and influence of PEEP setting. Respir Care. 2013 Nov;58(11):1886-91. doi: 10.4187/respcare.02129. Epub 2013 Apr 9.
PubMed 23571515Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.
PubMed 18270353
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
- ClinicalTrials.gov ID
- NCT00188058
- Acronym / sponsor ID
- ExPress / PHRC 01 - 02
- Keywords
- Acute respiratory distress syndrome, Positive end-expiratory pressure, Acute lung injury, Mechanical ventilation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2002 (actual)
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal alveolar distension | Active comparator | Device: Setting of positive end-expiratory pressurePEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O |
| Maximal alveolar distension | Experimental | Device: Setting of positive end-expiratory pressurePEEP is set for a plateau pressure between 28 and 30 cm H20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Setting of positive end-expiratory pressure | Device | Maximal alveolar distension, Minimal alveolar distension |
Primary outcome
Mortality at 28 days
Time frame: day 28
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Results publicationMercat A, Richard J, Brochard L. Comparison of two strategies for setting Peep in ALI/ARDS : EsPress Study.Intensive care med, 19th ESICM Annual Congress - Barcelona, Spain, 2006 Sep, Oral presentation 0365
- Derived from this study: PubMed 23571515Diehl JL, Coolen N, Faisy C, Osman D, Prat G, Sebbane M, Nieszkowska A, Gervais C, Richard JC, Richecoeur J, Brochard L, Mercat A, Guerot E, Borgel D. Growth-arrest-specific 6 (GAS6) protein in ARDS patients: determination of plasma levels and influence of PEEP setting. Respir Care. 2013 Nov;58(11):1886-91. doi: 10.4187/respcare.02129. Epub 2013 Apr 9.
- Derived from this study: PubMed 18270353Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALAIN MERCAT, MD principal investigator
University Hospital of Angers
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Setting of positive end-expiratory pressure in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by University Hospital, Angers at 46 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 28 days (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00188058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.