Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT00568659
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Specific Lung Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients in Supine and Prone Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2007-12-05', 'studyFirstSubmitQcDate': '2007-12-05', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific elastance', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gas exchange', 'Respiratory mechanics', 'Ventilator Induced Lung Injury'], 'conditions': ['Acute Lung Injury', 'Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators aim is to study the specific lung elastance in ALI/ARDS patients during invasive mechanical ventilation, in supine and prone position.', 'detailedDescription': 'In sedated and paralyzed ALI/ARDS patients, we study and compare the specific lung elastance in supine and prone position during invasive mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALI/ARDS patients during invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Haemodynamic failure, pneumothorax'}, 'identificationModule': {'nctId': 'NCT00568659', 'briefTitle': 'The Specific Lung Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients in Supine and Prone Position', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'The Specific Lung Elastance in ALI/ARDS Patients in Supine and Prone Position', 'orgStudyIdInfo': {'id': '1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Procedure: specific elastance']}], 'interventions': [{'name': 'specific elastance', 'type': 'PROCEDURE', 'description': 'The investigators study the specific lung elastance in ALI/ARDS patients in supine and prone position.', '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': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Davide Chiumello', 'investigatorAffiliation': 'Policlinico Hospital'}}}}