Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-18 @ 11:41 AM
Study NCT ID:
NCT02651935
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of intubation', 'timeFrame': '24th month', 'description': 'Time from intubation until extubation'}, {'measure': 'Duration of mechanical ventilation (NIV included)', 'timeFrame': '24th month', 'description': 'Total time patient remains on mechanical ventilation support (invasive or noninvasive)'}], 'secondaryOutcomes': [{'measure': 'Number of manual settings', 'timeFrame': '24th month', 'description': 'Number of adjusments made manually to set the ventilator'}, {'measure': 'Number of blood gas analysis tests', 'timeFrame': '24th month', 'description': 'Number of arterial blood gas tests under mechanical ventilation'}, {'measure': 'Weaning duration', 'timeFrame': '24th month', 'description': 'Time from the beginning of weaning until extubation'}, {'measure': 'Time spent on spontaneous ventilation', 'timeFrame': '24th month', 'description': 'Time patient actively triggers the ventilator'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiration, Artificial', 'weaning', 'critical care'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.', 'detailedDescription': 'COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation)\n* Age \\> 18 years\n* Written and/or informed consent\n\nExclusion Criteria:\n\n* Septic shock\n* Tracheostomy and/or home mechanical ventilation\n* Expected poor short term prognosis\n* Cardiac arrest with a poor neurological prognosis\n* ARDS\n* Broncho-pleural fistula'}, 'identificationModule': {'nctId': 'NCT02651935', 'briefTitle': 'Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}, 'officialTitle': 'A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients', 'orgStudyIdInfo': {'id': 'IGHCEAH-ICU-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intellivent ASV', 'description': 'Patients in this arm will be ventilated with Intellivent ASV. Intellivent ASV is an automatic close loop ventilation mode. FiO2 setting will be automatically adjusted according to patients SpO2 and minute volume will be automatically adjusted according to patients EtCO2.', 'interventionNames': ['Device: Intellivent ASV']}, {'type': 'NO_INTERVENTION', 'label': 'PCV+PSV', 'description': 'PCV+PSV is a conventional ventilation strategy of pressure controlled ventilation PCV) and pressure support ventilation (PSV).In this arm, FiO2, pressure control levels, respiratory frequency and all the ventilator settings will be manually adjusted by the physicians in charge.'}], 'interventions': [{'name': 'Intellivent ASV', 'type': 'DEVICE', 'description': 'Automated Invasive mechanical ventilation and weaning strategy', 'armGroupLabels': ['Intellivent ASV']}]}, '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': 'Ilknur Naz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Chest Diseases and Surgery Training Hospital'}, {'name': 'Burcu CINLETI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Chest Diseases and Surgery Training Hospital'}, {'name': 'Huseyin OZKARAKAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Chest Diseases and Surgery Training Hospital'}, {'name': 'Tunzala YAVUZ', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir 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': 'Associate Professor, Pulmonary and Critical Care Medicine', 'investigatorFullName': 'Cenk Kirakli, M.D.', 'investigatorAffiliation': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}}}}