Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT01074866
Status:
COMPLETED
Last Update Posted:
2012-09-21
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction
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': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-ventilator synchronization parameters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mechanical ventilation', 'Non invasive Ventilation', 'Patient-ventilator interaction', 'Pressure support', 'Neurally adjusted ventilatory assist'], 'conditions': ['Non Invasive Ventilation', 'Patient Ventilator Interaction']}, 'descriptionModule': {'briefSummary': 'The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin.', 'detailedDescription': 'The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin\n\nExclusion Criteria:\n\n* severe hypoxemia requiring an FIO2\\>0.6\n* hemodynamic instability\n* known oesophageal problem\n* active upper gastro-intestinal bleeding\n* any other contraindication to the insertion of a naso-gastric tube\n* impaired consciousness or absence of patient cooperation\n* facial or laryngeal lesions contraindicating the use of NIV\n* poor short term prognosis'}, 'identificationModule': {'nctId': 'NCT01074866', 'briefTitle': 'Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'The Effects of Neurally Adjusted Ventilatory Assist (NAVA) on Improving Patient-ventilator Interaction in Patients Undergoing Ventilation for Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'NAVA_NIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pressure support', 'description': 'Non invasive ventilation under pressure support (PS)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neurally Adjusted Ventilatory Assist', 'description': 'Non invasive ventilation under Neurally Adjusted ventilatory Assist', 'interventionNames': ['Device: Neurally Adjusted Ventilatory Assist']}], 'interventions': [{'name': 'Neurally Adjusted Ventilatory Assist', 'type': 'DEVICE', 'otherNames': ['NAVA'], 'description': 'Non invasive ventilation under Neurally adjusted Ventilatory Assist', 'armGroupLabels': ['Neurally Adjusted Ventilatory Assist']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'St Luc University hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Bernard Lambermont', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'HUG, University Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'CHUV University hospital of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Didier Tassaux, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HUG, University hospital Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital St Luc, Brussels', 'class': 'OTHER'}, {'name': 'University Hospital Sart Tilman, Liege', 'class': 'UNKNOWN'}, {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, {'name': 'Notre Dame de Grace Hospital, Gosselies', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Intensive Care Unit', 'oldOrganization': 'HUG, University hospital of Geneva'}}}}