Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT01280760
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2011-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triggering delay', 'timeFrame': 'Every inspiration, for 10 minutes', 'description': 'Duration between the onset of neural inspiration and the onset of insufflation'}], 'secondaryOutcomes': [{'measure': 'Cycling off delay', 'timeFrame': 'Every inspiration, for 10 minutes', 'description': 'Delay between the end of neural inspiration and the end of insufflation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Weaning Period']}, 'referencesModule': {'references': [{'pmid': '22610179', 'type': 'DERIVED', 'citation': 'Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.'}]}, 'descriptionModule': {'briefSummary': 'Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'NIV required on post extubation period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.\n\nExclusion Criteria:\n\n* Contra-indication to non-invasive ventilation\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01280760', 'acronym': 'NAVA-NIV', 'briefTitle': 'Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)', 'organization': {'class': 'OTHER', 'fullName': 'Pierre and Marie Curie University'}, 'officialTitle': 'Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)', 'orgStudyIdInfo': {'id': 'UPMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non invasive ventilation', 'description': 'Non-invasive ventilation after invasive mechanical ventilation weaning', 'interventionNames': ['Other: Device: Neurally Adjusted Ventilatory Assistance']}], 'interventions': [{'name': 'Device: Neurally Adjusted Ventilatory Assistance', 'type': 'OTHER', 'description': 'Device: Neurally Adjusted Ventilatory Assistance\n\nIn ICU following extubation NIV was performed as follows:\n\nfacial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode', 'armGroupLabels': ['Non invasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre and Marie Curie University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Matthieu SCHMIDT', 'investigatorAffiliation': 'Pierre and Marie Curie University'}}}}