Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-30 @ 11:50 PM
Study NCT ID:
NCT01090258
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2010-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2010-03-18', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '" not acceptable " zone of ventilation', 'timeFrame': 'During the four hours of the study protocol', 'description': 'Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined'}, {'measure': '" not acceptable " zone of ventilation', 'timeFrame': 'During the 4 hours of the protocol', 'description': 'Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'mechanical ventilation', 'automation', 'weaning'], 'conditions': ['Cardiac Surgery', 'Mechanically Ventilated Patients']}, 'referencesModule': {'references': [{'pmid': '23338569', 'type': 'DERIVED', 'citation': "Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22."}]}, 'descriptionModule': {'briefSummary': 'The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe.\n\nThe study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery.\n\nThe hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.', 'detailedDescription': 'Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery\n\nHypothesis:\n\nIntellivent will maintain the patient with " optimal ventilation " better than during usual management with a minimal number of interventions\n\nMonocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the " not acceptable " zone of ventilation and duration\n\nSecondary outcome:\n\nNumber of episodes in the " acceptable " zone of ventilation and duration Number of manual settings and duration of interventions Comparison of arterial blood gases Time to wean the FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria for consent (before surgical procedure):\n\n* Elective cardiac surgery\n* Age 18 to 90 years\n* Absence of pregnancy\n* Body Mass Index \\< 40 kg/m²\n* Creatinine \\< 200micromol/L)\n* Baseline PaCO2 \\> 50 mmHg)\n\nExclusion Criteria:\n\n* Unexpected surgical procedure\n* Major complication during surgery\n* Early extubation expected (\\< 1 hour)\n* Broncho-pleural fistula\n* Study ventilator not available'}, 'identificationModule': {'nctId': 'NCT01090258', 'acronym': 'CLOSER1', 'briefTitle': 'Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller', 'orgStudyIdInfo': {'id': 'CS-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automated settings', 'description': 'Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...)', 'interventionNames': ['Device: Hamilton ventilator (G5 modify to S1) Automated settings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'protocolized settings', 'description': 'Ventilator settings performed by the local respiratory therapists according to the local protocols', 'interventionNames': ['Other: Hamilton ventilator (G5) protocolized settings']}], 'interventions': [{'name': 'Hamilton ventilator (G5 modify to S1) Automated settings', 'type': 'DEVICE', 'otherNames': ['Intellivent'], 'description': 'Automated settings (respiratory rate \\[RR\\], FiO2, Insp and exp pressures) Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...)', 'armGroupLabels': ['Automated settings']}, {'name': 'Hamilton ventilator (G5) protocolized settings', 'type': 'OTHER', 'description': 'Mechanical ventilation settings performed by the respiratory therapists according to the local protocols', 'armGroupLabels': ['protocolized settings']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professeur', 'investigatorFullName': 'François Lellouche', 'investigatorAffiliation': 'Laval University'}}}}