Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT00963066
Status:
COMPLETED
Last Update Posted:
2010-03-03
First Post:
2009-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-02', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Subject-ventilator synchrony', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NAVA', 'Acute Lung Injury', 'Pressure Support Ventilation', 'Intubation', 'Tracheostomy', 'Mechanical ventilation'], 'conditions': ['Acute Lung Injury', 'Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.', 'detailedDescription': 'Physiological evaluation of two modes of mechanical ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation, at different levels of ventilator assistance.\n\nEvaluation in term of physiological parameters: Tidal volume, Respiratory rate, Inspiratory effort, PaCO2, evaluation of subject-ventilator synchrony.\n\nEvaluation of physiological response to varying levels of ventilator assistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Hospitalized in intensive care unit\n* Acute Lung Injury\n* Intubated or tracheotomized and mechanically ventilated\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Absence of consent'}, 'identificationModule': {'nctId': 'NCT00963066', 'briefTitle': 'NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.', 'orgStudyIdInfo': {'id': '2009-A00583-54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure Support ventilation', 'interventionNames': ['Device: PSV - pressure suppot ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'NAVA flow triggering', 'description': 'Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering', 'interventionNames': ['Device: NAVA - Neurally Adjusted Ventilatory Assist']}, {'type': 'EXPERIMENTAL', 'label': 'NAVA EMG triggering', 'description': 'Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram', 'interventionNames': ['Device: NAVA - EMG']}], 'interventions': [{'name': 'PSV - pressure suppot ventilation', 'type': 'DEVICE', 'otherNames': ['PSV'], 'description': 'Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Different levels of pressure support ventilator assistance are tested.', 'armGroupLabels': ['Pressure Support ventilation']}, {'name': 'NAVA - Neurally Adjusted Ventilatory Assist', 'type': 'DEVICE', 'otherNames': ['NAVA - Flow'], 'description': 'Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Positive pressure, delivered by the machine, is driven using inspiratory flow trigger.', 'armGroupLabels': ['NAVA flow triggering']}, {'name': 'NAVA - EMG', 'type': 'DEVICE', 'description': 'Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. The machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (Eadi). Eadi was obtained trhough a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden).', 'armGroupLabels': ['NAVA EMG triggering']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU de CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Nicolas TERZI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'TERZI Nicolas', 'oldOrganization': 'CHU de CAEN'}}}}