Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 7:03 AM
Study NCT ID:
NCT01238757
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-11-30', 'releaseDate': '2018-05-02'}], 'estimatedResultsFirstSubmitDate': '2018-05-02'}}, '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'}]}, '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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'asynchronies', 'timeFrame': '12 months', 'description': 'Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort.\n\nall ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min).\n\nAsynchronies will be determined by measuring each ventilatory cycle of all recordings.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prospective Studies', 'Humans, pediatric', 'Positive-Pressure Respiration/methods*', 'Respiration, Artificial/methods*', 'Intensive Care', 'Intensive Care Units/statistics & numerical data*', 'Respiration, Artificial/statistics & numerical data*', 'Patients/statistics & numerical data*', 'Prevalence', 'Respiratory Muscles/innervation', 'Child', 'Child, Preschool', 'Infant', 'Infant, Newborn', 'Intensive Care Units, Pediatric', 'Respiratory Rate*'], 'conditions': ['Respiratory Failure', 'Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is\n\n* to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.\n* to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support\n* and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).', 'detailedDescription': 'Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.\n\nCriteria for initiating non-invasive ventilation will follow the usual practice guidelines of the unit.\n\nVentilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant \\< 5 years), according to commonly applied guidelines in this unit.\n\nOne 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)above the initial set value, and will be recorded the following 5 minutes after stabilization.\n\nNAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava non-invasive-ventilation will be recorded during 20 minutes.\n\nThe 2 sessions, Pressure support and Nava, will be recorded consecutively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation\n\nExclusion Criteria:\n\n* Non treated pneumothorax\n* Hemodynamic instability\n* FiO2 \\> 0.6\n* Poor short term prognosis (defined as a high risk of death in the next seven days)\n* contraindication for gastric tube or obtention of a reliable EMGdi signal\n* Known esophageal problem (hiatal hernia, esophageal varicosities)\n* Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube\n* Neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT01238757', 'acronym': 'NavPed-NI', 'briefTitle': 'Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients', 'orgStudyIdInfo': {'id': 'HUG-matped 09-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Invasive Pressure support', 'description': 'in this arm, non-invasive pressure support will be recorded under 3 conditions:\n\nwith the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15%', 'interventionNames': ['Other: Non-invasive Ventilation under Pressure Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NAVA', 'description': 'Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm. Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.\n\nThe proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support', 'interventionNames': ['Other: Non-Invasive ventilation under NAVA']}], 'interventions': [{'name': 'Non-invasive Ventilation under Pressure Support', 'type': 'OTHER', 'otherNames': ['NIV-PS/initial settings', 'NIV-PS/ETS-10%', 'NIV-PS/ETS+10%'], 'description': 'Non-invasive Ventilation under Pressure Support:\n\n15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order', 'armGroupLabels': ['Non-Invasive Pressure support']}, {'name': 'Non-Invasive ventilation under NAVA', 'type': 'OTHER', 'otherNames': ['Neurally Adjusted ventilatory Assist', 'Neural ventilation', 'Diaphragmatic electrical activity ventilation'], 'description': '20 min session under non-invasive ventilation with NAVA', 'armGroupLabels': ['NAVA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'University hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Peter Rimensberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Peter Romensberger', 'investigatorFullName': 'Peter C. Rimensberger', 'investigatorAffiliation': 'University Hospital, Geneva'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-05-02', 'type': 'RELEASE'}, {'date': '2018-11-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Peter C. Rimensberger, Dr Peter Romensberger, University Hospital, Geneva'}}}}