Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT02056093
Status:
UNKNOWN
Last Update Posted:
2014-02-05
First Post:
2013-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Electrical diaphragm activity Gas exchange', 'timeFrame': 'February 2014', 'description': 'measured by the NAVA probe'}], 'primaryOutcomes': [{'measure': 'Breathing pattern variability', 'timeFrame': 'February 2014', 'description': 'The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)'}], 'secondaryOutcomes': [{'measure': 'Patient-ventilator asynchrony', 'timeFrame': 'February, 2014', 'description': 'Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NAVA - PAV- Breathing Variability - Asynchrony'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '25879592', 'type': 'DERIVED', 'citation': 'Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.'}]}, 'descriptionModule': {'briefSummary': "In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated patients.\n* Mechanical ventilation for a respiratory reason.\n* Expected duration of Mechanical ventilation \\> 48 hrs.\n* Spontaneous breathing.\n* Sedations stopped for more than 24 hours.\n\nExclusion Criteria:\n\n* \\- Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.\n* Main contra indications to PAV: airway leak, body weight \\<25 kg, neuromuscular diseases.\n* Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.\n* Severe hypoxemia defined as PaO2/FiO2 ratio \\<200.\n* Decision to withhold life-sustaining treatment.\n* Pregnant women.\n* Minors \\< 18 years.'}, 'identificationModule': {'nctId': 'NCT02056093', 'acronym': 'PAVANAVA', 'briefTitle': 'Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist', 'organization': {'class': 'OTHER', 'fullName': 'Pierre and Marie Curie University'}, 'officialTitle': 'Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist', 'orgStudyIdInfo': {'id': 'ADOREP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubated patients', 'description': 'Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.', 'interventionNames': ['Device: PSV mode', 'Device: PAV mode', 'Device: NAVA']}], 'interventions': [{'name': 'PSV mode', 'type': 'DEVICE', 'description': 'Application of PSV in all patients', 'armGroupLabels': ['Intubated patients']}, {'name': 'PAV mode', 'type': 'DEVICE', 'description': 'Application of PAV mode in all patients', 'armGroupLabels': ['Intubated patients']}, {'name': 'NAVA', 'type': 'DEVICE', 'armGroupLabels': ['Intubated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu SCHMIDT, MD', 'role': 'CONTACT', 'email': 'matthieuschmidt@yahoo.fr'}, {'name': 'Matthieu Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Matthieu SCHMIDT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie"}]}, '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'}}}}