Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-04-16 @ 7:55 AM
Study NCT ID:
NCT01881061
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non aerated lung area changes', 'timeFrame': '20 min after PEEP trial'}], 'secondaryOutcomes': [{'measure': 'Arterial oxygen and carbon dioxide partial pressure', 'timeFrame': '20 min after PEEP trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sonography', 'ICU', 'PEEP'], 'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '21816054', 'type': 'RESULT', 'citation': 'Stefanidis K, Dimopoulos S, Tripodaki ES, Vitzilaios K, Politis P, Piperopoulos P, Nanas S. Lung sonography and recruitment in patients with early acute respiratory distress syndrome: a pilot study. Crit Care. 2011 Aug 4;15(4):R185. doi: 10.1186/cc10338.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS.', 'detailedDescription': 'Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in critically ill patients.\n\nPatients with ARDS invariably require mechanical ventilation to improve oxygen transport. An improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (PEEP).\n\nIn critically ill patients with ARDS, lung imaging is been held by the use of chest radiography and the "gold standard" technique, Computed Tomography (CT).\n\nWe designed an observational study in which we included patients under mechanical ventilation admitted in our ICU. In all patients PEEP changes were applied and lung sonography was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ICU population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill patients with ARDS admitted in ICU of Evangelismos Hospital\n* length of stay \\> 48 hours\n\nExclusion Criteria:\n\n* age \\< 18 years\n* emphysema fractures or skin lesions that do not allow the implementation of lung sonography\n* BMI \\> 35 kg/m2\n* length of stay \\< 48 hours'}, 'identificationModule': {'nctId': 'NCT01881061', 'briefTitle': 'Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'orgStudyIdInfo': {'id': 'UOA-US-2010'}}, 'contactsLocationsModule': {'locations': [{'zip': '10676', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Serafim Nanas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Critical Care Medicine', 'investigatorFullName': 'Serafim Nanas', 'investigatorAffiliation': 'University of Athens'}}}}