Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-02 @ 7:31 AM
Study NCT ID:
NCT02773433
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAV vs Assist Control After Failed SBT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059725', 'term': 'Interactive Ventilatory Support'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-13', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients who meet criteria for enrollment who are approached in a timely manner', 'timeFrame': '1 year'}, {'measure': 'patient enrollment number over time', 'timeFrame': '1 year'}, {'measure': 'compliance with the ventilator settings', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Ventilation free days from the time patient is enrolled in the study', 'timeFrame': '1 year'}, {'measure': 'Development of ICU delirium Based on CAM ICU', 'timeFrame': '1 year'}, {'measure': 'Use of sedative or analgesic medications', 'timeFrame': '1 year'}, {'measure': 'Use of antipsychotic medications', 'timeFrame': '1 year'}, {'measure': 'Reintubations within 24 hrs', 'timeFrame': '1 year'}, {'measure': 'Length of stay in the intensive care unit', 'timeFrame': '1 year'}, {'measure': 'Length of stay in the hospital', 'timeFrame': '1 year'}, {'measure': 'Adverse events', 'timeFrame': '1 year'}, {'measure': 'In hospital mortality', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Weaning Mode Comparison']}, 'descriptionModule': {'briefSummary': 'The primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the ICU who require mechanical ventilation. The investigators plan to include patients on mechanical ventilation with low support (PaO2/FiO2 ratio \\> 200, FiO2 \\< 0.5 and PEEP \\< 8) for a period no longer than 48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.\n\nThe secondary aims are to determine the impact of proportional assist-ventilation (PAV) versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic medications, use of antipsychotic medications, length of stay in the intensive care unit and hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of patients.', 'detailedDescription': 'Overview of Design Randomized controlled pilot study comparing mechanical ventilation modes and daily spontaneous trial combination, in patients requiring invasive mechanical ventilation with low ventilator support (PaO2/Fio2 ratio \\> 200, FiO2 \\< 0.5 \\& PEEP \\<8) for a period not greater than 48 hrs.\n\nHypothesis The investigators hypothesize that 50 % of patients approached will agree to enrollment in this clinical trial over a period of 4 months. The investigators hypothesize 80% of the patients meeting inclusion criteria will be approached in a timely manner. The investigators also propose that PAV mode ventilation will be superior to ACV based on clinical outcome measurements.\n\nStudy Subjects Consecutive adult patients requiring invasive mechanical ventilation on low ventilator support (as mentioned above) for a period not greater than 48 hrs will be enrolled if they or their proxy consent for the study. The study will be performed in the intensive care units of University of Louisville and Jewish Hospital in Louisville, KY.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18 yrs old\n2. Patient or proxy available in the hospital to consent\n3. Receipt of invasive mechanical ventilation on low ventilator support (Po2/Fio2 ratio \\>200, Fio2 \\<60% \\& PEEP \\<8) for a period not greater than 48 hrs\n\nExclusion Criteria:\n\n1. Pregnant patients\n2. Terminal diseases (e.g. advanced or metastatic malignancy, liver cirrhosis with an estimated 3 month mortality \\> 50%)\n3. Severely depressed respiratory drive\n4. Receipt of neuromuscular blocker\n5. Bronchopleural fistula\n6. Inability to obtain consent from patients or their proxies.'}, 'identificationModule': {'nctId': 'NCT02773433', 'briefTitle': 'PAV vs Assist Control After Failed SBT', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14.1009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAV group', 'description': 'Using Proportional Assist Ventilation after failed Spontaneous Breathing Trial', 'interventionNames': ['Other: Proportional Assist Ventilation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Using Volume Assist Control mode after failed SBT'}], 'interventions': [{'name': 'Proportional Assist Ventilation', 'type': 'OTHER', 'otherNames': ['PAV'], 'armGroupLabels': ['PAV group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'UofLouisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Rodrigo Cavallazzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Rodrigo Cavallazzi', 'investigatorAffiliation': 'University of Louisville'}}}}