Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT00405002
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2006-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2006-11-27', 'studyFirstSubmitQcDate': '2006-11-27', 'lastUpdatePostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure'], 'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '19046447', 'type': 'DERIVED', 'citation': 'Chiumello D, Cressoni M, Chierichetti M, Tallarini F, Botticelli M, Berto V, Mietto C, Gattinoni L. Nitrogen washout/washin, helium dilution and computed tomography in the assessment of end expiratory lung volume. Crit Care. 2008;12(6):R150. doi: 10.1186/cc7139. Epub 2008 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators aim to evaluate a new system dedicated to estimate the end expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the helium dilution technique and the computed tomography (CT) scan.', 'detailedDescription': 'In this study we aimed to evaluate a new system dedicated to estimate the end expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the Helium dilution technique and the CT scan. We will compare the data considering the CT scan data as the gold standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALI/ARDS patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult intubated subjects\n\nExclusion Criteria:\n\n* Barotrauma'}, 'identificationModule': {'nctId': 'NCT00405002', 'briefTitle': 'A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation Acute in Intubated Patients', 'orgStudyIdInfo': {'id': '101020'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'ALI/ARDS patients', 'interventionNames': ['Procedure: Helium dilution technique, lung CT scan']}], 'interventions': [{'name': 'Helium dilution technique, lung CT scan', 'type': 'PROCEDURE', 'description': 'Helium dilution technique and lung CT scan', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}