Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00258518
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2005-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Mechanics and Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2005-11-23', 'studyFirstSubmitQcDate': '2005-11-23', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Role of pleural effusion and respiratory mechanics', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Critically ill patients'], 'conditions': ['Critically Ill', 'Acute Lung Injury', 'ARDS']}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.', 'detailedDescription': 'In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALI/ARDS patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALI/ARDS patients underwent invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Haemodynamic instability\n* Chronic obstructive pulmonary disease (COPD) patients'}, 'identificationModule': {'nctId': 'NCT00258518', 'briefTitle': 'Respiratory Mechanics and Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Estimation of Respiratory Mechanics (Respiratory System, Chest Wall and Lung Elastance) and Pleural Effusion at the Bedside With CT Scan.', 'orgStudyIdInfo': {'id': '1500'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'ALI/ARDS patients', 'interventionNames': ['Procedure: mechanical ventilation/CT Scan']}], 'interventions': [{'name': 'mechanical ventilation/CT Scan', 'type': 'PROCEDURE', 'description': 'evaluation of pleural effusion and respiratory mechanics, CT scan', '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'}}}}