Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00284102
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2006-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PEEP Test and Gas Exchange in ALI/ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-24', 'studyFirstSubmitDate': '2006-01-30', 'studyFirstSubmitQcDate': '2006-01-30', 'lastUpdatePostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gas exchange, dead space, respiratory mechanics', 'timeFrame': '5, 15, 30, 60 minutes from PEEP change'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gas exchange', 'dead space', 'respiratory failure', 'ALI/ARDS patients'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.', 'detailedDescription': 'In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALI/ARDS patients requiring mechanical ventilation\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Barotrauma'}, 'identificationModule': {'nctId': 'NCT00284102', 'briefTitle': 'PEEP Test and Gas Exchange in ALI/ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Positive End Expiratory Pressure (PEEP) Test and Gas Exchange in ALI/ARDS Patients', 'orgStudyIdInfo': {'id': '1700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ALI/ARDS patients', 'interventionNames': ['Procedure: Mechanical ventilation']}], 'interventions': [{'name': 'Mechanical ventilation', 'type': 'PROCEDURE', 'description': 'measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Policlinico Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Davide Chiumello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Davide Chiumello', 'oldOrganization': 'Policlinico Hospital'}}}}