Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-01 @ 3:21 AM
Study NCT ID:
NCT00969605
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2009-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Support Ventilation in the Weaning of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weaning duration'}], 'secondaryOutcomes': [{'measure': 'Weaning success'}, {'measure': 'Length of stay in the ICU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weaning', 'adaptive support ventilation', 'COPD'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD\n* On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure\n\nExclusion Criteria:\n\n* Mechanical ventilation less then 24 hours (self extubation or death),\n* Having a tracheotomy and\n* COPD coexisted with severe cardiac or neurologic diseases.'}, 'identificationModule': {'nctId': 'NCT00969605', 'briefTitle': 'Adaptive Support Ventilation in the Weaning of COPD', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}, 'officialTitle': 'Adaptive Support Ventilation for Faster Weaning in COPD: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IGCEH-ICU-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure support ventilation', 'interventionNames': ['Procedure: Comparison of two different modes for weaning from mechanical ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adaptive support ventilation', 'interventionNames': ['Procedure: Comparison of two different modes for weaning from mechanical ventilation']}], 'interventions': [{'name': 'Comparison of two different modes for weaning from mechanical ventilation', 'type': 'PROCEDURE', 'otherNames': ['weaning protocol'], 'description': 'Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.', 'armGroupLabels': ['Adaptive support ventilation', 'Pressure support ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35210', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Cenk Kirakli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izmir Dr Suat Seren Chest Diseases and Chest Surgery Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cenk Kirakli,MD', 'oldOrganization': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit'}}}}