Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT01472302
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2011-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-05', 'studyFirstSubmitDate': '2011-11-11', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Failure', 'All Intubated Patients']}, 'referencesModule': {'references': [{'pmid': '25742308', 'type': 'DERIVED', 'citation': 'Kirakli C, Naz I, Ediboglu O, Tatar D, Budak A, Tellioglu E. A randomized controlled trial comparing the ventilation duration between adaptive support ventilation and pressure assist/control ventilation in medical patients in the ICU. Chest. 2015 Jun;147(6):1503-1509. doi: 10.1378/chest.14-2599.'}]}, 'descriptionModule': {'briefSummary': 'Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated and mechanically ventilated ICU patients for more than 24 hours\n\nExclusion Criteria:\n\n* Patient with a tracheostomy\n* Patients under home mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT01472302', 'briefTitle': 'Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}, 'officialTitle': 'Effect of a Closed Loop Ventilation Strategy on Reducing the Total Duration of Mechanical Ventilation of Intubated Intensive Care Unit Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IGCEAH-ICU 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASV', 'description': 'Adaptive Support Ventilation', 'interventionNames': ['Device: Adaptive Support Ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCV', 'description': 'Pressure Controlled Ventilation', 'interventionNames': ['Device: Pressure Controlled Ventilation']}], 'interventions': [{'name': 'Adaptive Support Ventilation', 'type': 'DEVICE', 'description': 'Ventilation protocol according to the patients ideal body weight', 'armGroupLabels': ['ASV']}, {'name': 'Pressure Controlled Ventilation', 'type': 'DEVICE', 'description': 'Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU', 'armGroupLabels': ['PCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35550', 'city': 'Izmir', 'state': 'Yenisehir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Cenk Kirakli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Director of ICU', 'investigatorFullName': 'Cenk Kirakli', 'investigatorAffiliation': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}}}}