Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-03 @ 7:39 AM
Study NCT ID:
NCT01577667
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intellivent Versus Conventional Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '48 Hours', 'description': 'Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR) values considered as non-optimal, as defined a priori and consensually by a panel of experts.'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '48 Hours', 'description': 'Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat-proxi and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.\n\nEfficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.'}, {'measure': 'Care workload', 'timeFrame': '48H', 'description': 'Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['automation', 'closed loop', 'oxygenation', 'ventilation'], 'conditions': ['Respiratory Failure', 'Self Efficacy']}, 'descriptionModule': {'briefSummary': 'Partial automation of mechanical ventilation in resuscitation has been available for several years. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®.\n\nThis pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a conventional ventilation modality.', 'detailedDescription': 'Rational: Partial automation of mechanical ventilation in resuscitation has been available for several years. It can deliver a continuous ventilation adapted in real time to the patient\'s clinical condition,and decrease care workload and ventilation weaning duration. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®) and preliminary studies show that over short periods (2 to 4 h) such a system can ventilate patients more optimally and more safely, with a better ventilation efficiency (comparable effect on gas exchanges for a less "aggressive" ventilation). This pilot study compares over a longer period (48 hours), the safety and efficacy of IntelliVent®, versus a usual ventilation modality.\n\nType of study: Monocenter, comparative, prospective, randomized, parallel study.\n\nObjective: To assess IntelliVent® safety, efficacy, and care workload.\n\nAssessment criteria:\n\n* Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR),values considered as non-optimal, as defined a priori and consensually by a panel of experts.\n* Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.\n\nEfficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.\n\n\\- Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.\n\nNumber of subjects: 80 patients receiving invasive mechanical ventilation for acute respiratory failure.\n\nMethods: The selected patients presenting with inclusion criteria are ventilated either with IntelliVent® or with the unit\'s usual ventilation following a random selection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patient under invasive ventilation for more than 6 hours and for a planned duration of at least 48 hours\n* Body Mass Index (current weight (kg)/height (m)²) \\< 40\n* Signature of an informed consent by the family\n\nExclusion Criteria:\n\n* Need for ventricular assistance with intra-aortic balloon counterpulsation.\n* Presence of a bronchopleural fistula\n* Pregnant women: A pregnancy blood test will be performed in women of reproductive age. The results will be communicated to the patient by a physician of her choice.\n* Adults under guardianship\n* People deprived of freedom\n* Inclusion in another study protocol under consent'}, 'identificationModule': {'nctId': 'NCT01577667', 'acronym': 'Intellivent', 'briefTitle': 'Intellivent Versus Conventional Ventilation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamilton Medical AG'}, 'officialTitle': 'Comparative Monocenter RCT Comparing Safety and Efficacy of an Automated Closed-loop Oxygenation and Ventilation(IntelliVent® System - HAMILTON MEDICAL AG) With Non-automated Conventional Ventilation and Oxygenation', 'orgStudyIdInfo': {'id': 'Intellivent RCT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional ventilation', 'description': 'Usual ventilation is administered according to the protocols implemented in the unit'}, {'type': 'EXPERIMENTAL', 'label': 'Intellivent', 'description': 'Intellivent is a ventilatory mode included in ventilator S1, Hamilton Medical. Intervention: the patient is ventilated with the same ventilator than in the conventionnal group; but the "ASV-Intellivent" ventilation has to be activated via a dedicated key on the ventilator screen.\n\nIntelliVent® activation requires selecting the kind of patient: ARDS, COPD and whether hemodynamic instability exists.\n\nThe initial settings are IntelliVent® by default settings (% MV: 110%, PEEP: 5 cm H2O, FiO2: 60% - 100% in case of ARDS).\n\nTherefore modification of these various parameters is automatic. FiO2 and PEP are modified according to SpO2; %MV according to EtCO2.', 'interventionNames': ['Device: Intellivent; automatic mode implemented on a S1 ventilator']}], 'interventions': [{'name': 'Intellivent; automatic mode implemented on a S1 ventilator', 'type': 'DEVICE', 'otherNames': ['Closed-loop ventilation'], 'description': 'Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2', 'armGroupLabels': ['Intellivent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Polyvalent Intensive Care, St Luc Clinics', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pierre-François Laterre, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reanimation, Cliniques Universitaires Saint Luc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Medical AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}