Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT05644418
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2022-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EIT During FCV in the Intensive Care Unit
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'PCV at baseline, followed by 90 minutes of FCV and finished with 30 minutes of PCV'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End-expiratory lung volume', 'timeFrame': 'Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)', 'description': 'The difference in End-expiratory lung volume (EELV) between PCV and FCV is measured using the difference in End-expiratory lung impedance (EELI) and tidal volume at baseline'}], 'secondaryOutcomes': [{'measure': 'Minute volume', 'timeFrame': 'The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV)', 'description': 'The difference in minute volume between PCV and FCV with a stable PaCO2'}, {'measure': 'Mechanical Power', 'timeFrame': 'The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization)', 'description': 'The difference in Mechanical Power between PCV and FCV are measured by using our own produced Pressure-Volume loops'}, {'measure': 'Dissipated energy', 'timeFrame': 'The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)', 'description': 'The difference in Dissipated energy between PCV and FCV are measured by using our own produced Pressure-Volume loops'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FCV', 'EIT', 'Mechanical Power', 'Minute volume', 'Dissipated energy', 'ICU'], 'conditions': ['Post-cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '38502268', 'type': 'DERIVED', 'citation': 'Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV.\n\nThe main questions it aims to answer are:\n\n* What is the effect of FCV on the lung volume measured by Electrical Impedance Tomography (EIT)?\n* What is the effect of FCV on the minute volume?\n* What is the effect of FCV on the mechanical power and dissipated energy?\n\nParticipants will be ventilated with PCV at baseline and then switched to FCV for 90 minutes while the lung volume, minute volume and mechanical power and dissipated energy levels are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older;\n* Informed consent form signed by the subject or a legal representative;\n* Controlled mechanical ventilation via an endotracheal tube -\n* FiO2 ≤50% and PEEP 10 cmH2O or lower\n\nExclusion Criteria:\n\n* Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)\n* Severe respiratory insufficiency defined as a PaO2 to FiO2 ratio of \\<100mmHg or moderate to severe ARDS according to the Berlin definition of ARDS\n* Untreated pneumothorax (i.e. no pleural drainage)\n* Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose \\>0.4mg/kg/min\n* Excessive subcutaneous emphysema (prevents proper functioning of the EIT device)\n* Thoracic wounds, bandages or other obstruction which prevent proper functioning of the EIT device\n* High (\\>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure\n* An inner tube diameter of 6mm or less'}, 'identificationModule': {'nctId': 'NCT05644418', 'briefTitle': 'EIT During FCV in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit', 'orgStudyIdInfo': {'id': 'NL 68962.078.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Postcardiac surgery ICU-patients', 'description': 'After postcardiac surgery patients are brought to the ICU and are ventilated on PCV (Pressure Controlled Ventilation). Measurements of the lung volume (by Electrical Impedance Tomography; EIT), the minute volume and Mechanical Power/Dissipated energy are started and continued for the duration of the study. After a few minutes the patient is switched to FCV (Flow Controlled Ventilation) for 90 minutes and afterwards PCV is resumed with the measurements lasting for another 30 minutes (total study time 120 minutes).', 'interventionNames': ['Device: Flow Controlled Ventilation (FCV)']}], 'interventions': [{'name': 'Flow Controlled Ventilation (FCV)', 'type': 'DEVICE', 'description': 'FCV is started with the same settings as PCV (PEEP, Ppeak, FiO2) and after 30 minutes FCV is optimized concerning the driving pressure and PEEP using the dynamic compliance. After a total of 60 minutes the flow is adjusted based on the arterial blood gas.', 'armGroupLabels': ['Postcardiac surgery ICU-patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Henrik Endeman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus MC, Rotterdam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ventinova', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'H. Endeman, MD, PhD, Principle Investigator', 'investigatorFullName': 'Henrik Endeman', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}