Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-27 @ 3:54 AM
Study NCT ID:
NCT02774304
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2016-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062666', 'term': 'Vascular Access Devices'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic Elastance', 'timeFrame': '2 minutes', 'description': 'determination of stroke volume and pulse pressure variation: ratio of SPV/SVV'}], 'secondaryOutcomes': [{'measure': 'Stroke volume variation (SVV)', 'timeFrame': '2 minutes', 'description': 'Variation of stroke volume (area under the arterial or oxygen saturation curve) during mechanical ventilation'}, {'measure': 'Systolic pressure variation (SPV)', 'timeFrame': '2 minutes', 'description': 'Variation of systolic pressure or peak oxygen saturation during mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elastance', 'fluid responsiveness'], 'conditions': ['Hypovolemia']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to determine Eadyn as a functional measure of arterial load, in conjunction with other actual afterload indices, derived from both invasive arterial pressure tracing and non-invasive signals, such as arterial saturation, non-invasive cardiac output obtained by bio-reactance, and non-invasive stroke volume. A secondary aim is the correlation of the different non-invasive signals with the invasive arterial pressure tracing characteristics.', 'detailedDescription': 'Fifteen patients, who provide written informed consent, will be included. All of them are scheduled for a major surgical intervention, in whom standard haemodynamic monitoring includes arterial pressure monitoring.\n\nNon-invasive wired patches, connected to a Cheetah cardiac output monitor, will be installed, as well as traditional haemodynamic monitoring (ECG, SaO2, non-invasive blood pressure). A computer link between a Philips monitor (MP50 or MP70) is made, to obtain selected curves in a digital format for post-intervention processing. After awake insertion of an arterial catheter in the radial or brachial artery and induction of anaesthesia, patient becomes intubated and mechanically ventilated.\n\nBefore surgery, following data will be registered for 5 min.: ECG, invasive arterial pressure tracing, cardiac output (Cheetah monitor), SaO2 tracing, arterial pressure tracing and pulse pressure and stroke volume variation (Nexfin).\n\nWhen SVV \\> 15%, the operation table will be put in Passive Leg Raising (PLR) to optimize the filling status of the patient (test of preload dependency). When positive haemodynamic reaction is present, the patients will obtain a rapid infusion bolus of 250 ml of crystalloids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled for a major surgical intervention, in whom standard haemodynamic monitoring includes arterial pressure monitoring.\n\nExclusion Criteria:\n\n* Minor surgery and absence of arterial pressure monitoring'}, 'identificationModule': {'nctId': 'NCT02774304', 'acronym': 'Eadyn', 'briefTitle': 'Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load, Derived From Both Non-invasive and Invasive Haemodynamic Variables.', 'orgStudyIdInfo': {'id': 'Eadyn version 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'arterial line', 'description': 'invasive haemodynamic monitoring', 'interventionNames': ['Device: arterial line', 'Device: Cheetah®']}, {'type': 'EXPERIMENTAL', 'label': 'Cheetah®', 'description': 'non-invasive cardiac output', 'interventionNames': ['Device: arterial line', 'Device: Cheetah®']}], 'interventions': [{'name': 'arterial line', 'type': 'DEVICE', 'description': 'In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.', 'armGroupLabels': ['Cheetah®', 'arterial line']}, {'name': 'Cheetah®', 'type': 'DEVICE', 'description': 'In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.', 'armGroupLabels': ['Cheetah®', 'arterial line']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'Michel Vervoort, Ir', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Jan Poelaert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Tina Maes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Data Nurse', 'investigatorFullName': 'Veerle Van Mossevelde', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}