Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-04 @ 7:57 PM
Study NCT ID:
NCT01570933
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059725', 'term': 'Interactive Ventilatory Support'}, {'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-06', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the percentage of asynchronies during the nava mode', 'timeFrame': 'from minute zero to minute 90', 'description': "One of the aims of the NAVA mode is to provide better synchronization between the child's breathing needs and the breathing cycles given by the ventilator. By comparing the EDI curve (electric activity of the diaphragm of the child) and the flow and pressure curves of the ventilator, it is possible to determine the percentage of asynchronies during the nava mode"}], 'secondaryOutcomes': [{'measure': 'Comparison of breathing rhythm between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}, {'measure': 'Comparison of PEEP (positive end expiratory pressure) between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}, {'measure': 'Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}, {'measure': 'Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}, {'measure': 'Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}, {'measure': 'Comparison of PaCO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}, {'measure': 'Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode', 'timeFrame': 'from minute zero to minute 90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardio-pulmonary bypass'], 'conditions': ['Heart Defects, Congenital', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '25691764', 'type': 'DERIVED', 'citation': 'Houtekie L, Moerman D, Bourleau A, Reychler G, Detaille T, Derycke E, Clement de Clety S. Feasibility Study on Neurally Adjusted Ventilatory Assist in Noninvasive Ventilation After Cardiac Surgery in Infants. Respir Care. 2015 Jul;60(7):1007-14. doi: 10.4187/respcare.03624. Epub 2015 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows, through an oesophageal catheter, to record the electrical activity of the diaphragm and thereby synchronize breaths from the ventilator on the inspiratory efforts of the child. Moreover, the pressure support delivered by the ventilator may be proportional to the diaphragmatic effort developed by the child. This mode, associated with the interface Miniflow®, could increase the comfort of the child by allowing a more efficient synchronization and reducing its respiratory work. To our knowledge, this ventilation mode with this interface has not been evaluated in the postoperative period of cardiac surgery in the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory mode and evaluate its influence on ventilatory parameters of this category of infants.', 'detailedDescription': 'Study Design:\n\nSingle centre prospective crossover study\n\nStudy Objectives:\n\nMain objectives:\n\n* Assessment of the feasibility of non invasive ventilation in NIV-NAVA mode via Miniflow® interface in infants of less than 3.5 kg after cardiac surgery with cardiopulmonary bypass.\n* Evaluation of the following parameters:\n\n * Implementation of the interface\n * Air leaks\n * Placement and contention of oesophageal probe\n * Quality of synchronization\n * Obstruction of the probe\n * Risk of nasal wounds\n\nSecondary objectives:\n\n* Comparison of ventilation parameters between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode\n* Evaluation of the following parameters:\n\n * Breathing rhythm\n * Tidal volume\n * PEEP\n * Inspiratory pressure\n * FiO2\n * PaO2\n * PaCO2\n * pH\n* Evolution of EAdi min and EAdi max parameters in NIV-NAVA mode (EAdi : diaphragmatic electric activity)\n\nConduct of the study:\n\nFirst phase: placement of EADI catheter and extubation\n\nWhen extubation criteria are met, the oesophageal EADI catheter is placed according to the manufacturer\'s instructions. The ventilation mode is then switched to Pressure Support Mode with the same Peep as in the previous mode and a pressure support of 10 cmH2O.\n\nDuring 30 minutes, trends in respiratory rate, tidal volume, PEEP, inspiratory pressure, FiO2, EADI min, EADi max are recorded.\n\nAfter 30 minutes, an arterial blood gas analysis is performed to determine the values of PaCO2, PaO2 and pH before randomization.\n\nThe child is extubated according to the procedures of the service and the non-invasive ventilation relay is introduced through the Miniflow® interface with nasal prongs adapted to the morphology of the child. An adrenaline nebulisation can be given before starting NIV in case of respiratory distress due to laryngeal oedema.\n\nSecond phase: nCPAP or NIV-NAVA\n\nFollowing randomisation, the child is included in the "nCPAP first" arm or "NIV-NAVA first" arm and is ventilated in the designated mode for 30 minutes. During the first 15 minutes, the ventilation parameters are adapted according to the procedures below:\n\nnCPAP parameters adaptation:\n\n* PEEP and FiO2 as previously set in invasive ventilation;\n* FiO2 according to target SpO2 values of the child and/or 10% higher than FiO2 in invasive ventilation mode;\n* PEEP between 4-6 cmH2O in order to minimize respiratory efforts.\n\nNIV-NAVA parameters adaptation:\n\n* PEEP and FiO2 as previously set in invasive ventilation;\n* Adaptation of the NIV-NAVA level to reach a EADi level equal to the mean EADi level over the last 5 minutes of the invasive mode. Inspiratory pressure and tidal volume are limited respectively to 30 cmH2O and 8 ml/kg.\n* FiO2 according to target SpO2 values of the child and/or 10% higher than FiO2 in invasive ventilation mode ;\n* PEEP between 4-6 cmH2O in order to minimize respiratory efforts.\n\nOver the last 15 minutes of this ventilation mode, trends in respiratory rate, tidal volume, PEEP, inspiratory pressure, FiO2, EADI min, EADi max are recorded.\n\nOn Minutes M16, M21 and M29 in NIV-NAVA mode, synchronisation data are recorded : auto-triggering, double triggering, inspiration beginning and ending.\n\nAfter 30 minutes, an arterial blood gas analysis is performed to determine the evolution of the values of PaCO2, PaO2 and pH.\n\nAt any time, if the re-intubation criteria are met, the child is re-intubated and returned to conventional ventilation. He is then excluded of the study.\n\nThird phase: nCPAP or NIV-NAVA\n\nThe ventilation mode is changed from nCPAP to NIV-NAVA or from NIV-NAVA to nCPAP. The adaptation protocol and the recorded parameters are the same as in the second phase.\n\nAfter 30 minutes, an arterial blood gas analysis is performed to determine the evolution of the values of PaCO2, PaO2 and pH.\n\nAt any time, if the re-intubation criteria are met, the child is re-intubated and returned to conventional ventilation. He is then excluded of the study.\n\nFourth phase: end of the study\n\nThe study concludes at the end of the third phase. The child is left in the better tolerated ventilation mode, as judged by the clinician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight ≤ 5 kg\n* Postoperative period of cardiac surgery with cardiopulmonary bypass (max 10 days after surgery)\n* Conventional ventilation\n* Agreement with the extubation criteria\n* Arterial line\n\nExclusion Criteria:\n\n* High frequency oscillation ventilation\n* Extubation criteria not fulfilled\n* Proven or suspected sepsis\n* Absence of arterial line\n* Oesophageal pathology (Excepted gastro-oesophageal reflux)'}, 'identificationModule': {'nctId': 'NCT01570933', 'acronym': 'NIVNAVA', 'briefTitle': 'Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Feasibility Study Over the Neurally Adjusted Ventilatory Assist (NAVA) Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.', 'orgStudyIdInfo': {'id': 'SIP2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAVAfirst', 'description': 'Starting crossover by NIVnava mode', 'interventionNames': ['Device: NivNava']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cpap first', 'description': 'Start crossover by Cpap on nasal canula', 'interventionNames': ['Device: Cpap']}], 'interventions': [{'name': 'NivNava', 'type': 'DEVICE', 'otherNames': ['Neurally adjusted ventilatory assist'], 'description': 'Non-invasive Nava ventilation mode on nasal cannula', 'armGroupLabels': ['NAVAfirst']}, {'name': 'Cpap', 'type': 'DEVICE', 'otherNames': ['InfantFlow(R), CareFusion(R), SanDiego, Ca, USA'], 'description': 'nasal Cpap on nasal cannula', 'armGroupLabels': ['Cpap first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Univeristaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Laurent Houtekie, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques Universitaires Saint-LUc, Brussels'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}