Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00188058
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055370', 'term': 'Lung Injury'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 768}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at 28 days', 'timeFrame': 'day 28'}], 'secondaryOutcomes': [{'measure': 'Mortality at 60 days', 'timeFrame': 'day 60'}, {'measure': 'In hospital mortality', 'timeFrame': 'day 60'}, {'measure': 'Ventilator free Days through day 28', 'timeFrame': 'day 28'}, {'measure': 'Number of new organ failure before day 28', 'timeFrame': 'day 28'}, {'measure': 'Proportion of patients alive and unassisted breathing at 28 days', 'timeFrame': 'day 28'}, {'measure': 'Number of patients with pneumothorax', 'timeFrame': 'day 28'}, {'measure': 'Number of days alive between the first positive "potential weanability test" and day 28', 'timeFrame': 'day 28'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute respiratory distress syndrome', 'Positive end-expiratory pressure', 'Acute lung injury', 'Mechanical ventilation', 'Randomized controlled trial'], 'conditions': ['Acute Respiratory Distress Syndrome', 'Acute Lung Injury']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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'}, {'pmid': '23571515', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '18270353', 'type': 'DERIVED', 'citation': 'Mercat 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical ventilation through an endotracheal tube\n* Bilateral infiltrates consistent with pulmonary edema\n* PaO2/FiO2 \\< 300 mmHg\n* No clinical evidence of left atrial hypertension. If measured, pulmonary artery occlusion pressure \\< 18 mmHg\n* Criteria 1, 2 et 3 jointly present for less than 48 hours\n* Written informed consent obtained from the patient or surrogate\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnancy\n* Expected duration of mechanical ventilation through an endotracheal tube \\< 48 hours\n* Participation in other trials within the previous 30 days\n* Increased intracranial pressure\n* Severe chronic respiratory disease\n* Morbid obesity (weight \\> 1kg/cm)\n* Sickle cell disease\n* Bone marrow transplant or chemotherapy-induced neutropenia\n* Extended burns (\\> 30 % total body surface area)\n* Severe chronic liver disease (Child-Pugh score C)\n* Pneumothorax'}, 'identificationModule': {'nctId': 'NCT00188058', 'acronym': 'ExPress', 'briefTitle': 'Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).', 'orgStudyIdInfo': {'id': 'PHRC 01 - 02'}, 'secondaryIdInfos': [{'id': 'DGS : 2002 - 0381'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Minimal alveolar distension', 'description': 'PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O', 'interventionNames': ['Device: Setting of positive end-expiratory pressure']}, {'type': 'EXPERIMENTAL', 'label': 'Maximal alveolar distension', 'description': 'PEEP is set for a plateau pressure between 28 and 30 cm H20', 'interventionNames': ['Device: Setting of positive end-expiratory pressure']}], 'interventions': [{'name': 'Setting of positive end-expiratory pressure', 'type': 'DEVICE', 'armGroupLabels': ['Maximal alveolar distension', 'Minimal alveolar distension']}]}, 'contactsLocationsModule': {'locations': 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'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}