Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01926093
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2013-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis', 'timeFrame': '1 day', 'description': 'We measured lung recruitment with visual and quantitative analysis both on standard and low dose CT scan.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Distress Syndrome (ARDS)'], 'conditions': ['Acute Respiratory Distress Syndrome (ARDS)']}, 'descriptionModule': {'briefSummary': 'We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ARDS patients fulfilling the Berlin definition criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Respiratory Distress Syndrome\n* CT scan performed for clinical purposes\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT01926093', 'briefTitle': 'Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'orgStudyIdInfo': {'id': 'Policlinico-08'}, 'secondaryIdInfos': [{'id': '3102-28/12/2012'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "IRCCS Ca' Granda - Ospedale MAggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Davide Chiumello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "IRCCS Ca' Granda - Ospedale MAggiore Policlinico"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Davide Chiumello', 'investigatorAffiliation': 'Policlinico Hospital'}}}}