Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 7:38 PM
Study NCT ID:
NCT03217305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2017-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The investigator works as physician at the Department of Intensive Care. The participants are patients.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Control-Intervention-Control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2017-06-21', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilation distribution', 'timeFrame': 'Through study completion, within approximately 18 months', 'description': 'Redistribution of ventilation , dorsally vs. ventrally'}, {'measure': 'Alveolar dead space', 'timeFrame': 'Through study completion, within approximately 18 months', 'description': 'Calculated from blood gases and end tidal pCO2,using standard formulae'}, {'measure': 'End expiratory lung impedance', 'timeFrame': 'Through study completion, within approximately 18 months', 'description': 'Measured by Electric Impedance Tomography'}, {'measure': 'PaO2/FiO2', 'timeFrame': 'Through study completion, within approximately 18 months', 'description': 'Arterial oxygenation'}, {'measure': 'Alveolar shunt', 'timeFrame': 'Through study completion, within approximately 18 months', 'description': 'Calculated from mixed venous and arterial blood gases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EIT. NAVA. Endexpiratory Lung Impedance.'], 'conditions': ['Ventilator Lung']}, 'referencesModule': {'references': [{'pmid': '41423634', 'type': 'DERIVED', 'citation': 'Martinsson A, Lundholm C, Ricksten SE, Oras J, Magnusson JM, Wallinder A, Sellgren J, Thoren A. Neurally adjusted ventilatory assist vs pressure support ventilation: short-term effects on shunt and dead space after cardiac surgery. Sci Rep. 2025 Dec 21;15(1):44234. doi: 10.1038/s41598-025-33097-1.'}]}, 'descriptionModule': {'briefSummary': 'The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation.', 'detailedDescription': 'The aim of the study is to compare two different ventilation modes in complicated postcardiac surgery patients, who need ventilatory support during weaning phase, in the Cardiothoracic Intensive Care Unit. The two different ventilation modes are Neuronally Adjusted Ventilatory Assist (NAVA) and Pressure Support ventilation. NAVA ventilation mode have been introduced a couple of years ago as an alternative to pressure support. The advantage of NAVA mode compared to pressure support is a better synchrony between patient and ventilator in the inspired and expired phases. Maybe there are also physiological advantages of the NAVA mode, which we want to study in the present study.\n\nAll patients have three measurement periods. 1) Pressure support during 20 min, NAVA equilibration period of 30 min, followed by 2) NAVA ventilation for 20 min, pressure support equilibration period of 30 min and 3) pressure support for 20 min. Blood gases and cardiac output measurements is performed before and after each measurement period. Regional ventilation is measured by Electric Impedance Tomography (EIT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complicated Post Cardiac surgery patients in the ventilator weaning phase.\n* Patients requiring assisted ventilation\n* Respiratory and circulatory stable patients\n* Sedated patients, RASS -2 to -3\n\nExclusion Criteria:\n\n* Transplanted patients\n* Pleural effusion.'}, 'identificationModule': {'nctId': 'NCT03217305', 'briefTitle': 'Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study', 'orgStudyIdInfo': {'id': 'AMartinssonthorax2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'NAVA vs Pressure Support', 'description': 'Control (pressure support) - NAVA - Control (Pressure Support) Intervention is NAVA', 'interventionNames': ['Device: NAVA']}], 'interventions': [{'name': 'NAVA', 'type': 'DEVICE', 'description': 'Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode', 'armGroupLabels': ['NAVA vs Pressure Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Anders Thoren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Goteborg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andreas Martinsson', 'investigatorAffiliation': 'Göteborg University'}}}}