Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-04-16 @ 12:22 AM
Study NCT ID:
NCT02678559
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D020896', 'term': 'Hypovolemia'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of stroke volume', 'timeFrame': 'at the beginning of cardiac surgery', 'description': 'Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'Velocity time integral (cm)', 'timeFrame': 'at the begining of cardiac surgery', 'description': 'Velocity time integral (cm) (TEE measurement)'}, {'measure': 'Velocity time integral (cm)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.', 'description': 'Velocity time integral (cm) (TEE measurement)'}, {'measure': 'Velocity time integral (cm)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed', 'description': 'Velocity time integral (cm) (TEE measurement)'}, {'measure': 'Cardiac index (l/min/m2)', 'timeFrame': 'at the begining of cardiac surgery', 'description': 'Cardiac index (l/min/m2) (TEE measurement)'}, {'measure': 'Cardiac index (l/min/m2)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.', 'description': 'Cardiac index (l/min/m2) (TEE measurement)'}, {'measure': 'Cardiac index (l/min/m2)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed', 'description': 'Cardiac index (l/min/m2) (TEE measurement)'}, {'measure': 'Right ventricle diameter/left ventricle diameter ratio', 'timeFrame': 'at the begining of cardiac surgery', 'description': 'Right ventricle diameter/left ventricle diameter ratio (TEE measurement),'}, {'measure': 'Right ventricle diameter/left ventricle diameter ratio', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.', 'description': 'Right ventricle diameter/left ventricle diameter ratio (TEE measurement),'}, {'measure': 'Right ventricle diameter/left ventricle diameter ratio', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed', 'description': 'Right ventricle diameter/left ventricle diameter ratio (TEE measurement),'}, {'measure': 'E/A ratio', 'timeFrame': 'at the begining of cardiac surgery', 'description': 'E/A ratio (TEE measurement)'}, {'measure': 'E/A ratio', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.', 'description': 'E/A ratio (TEE measurement)'}, {'measure': 'E/A ratio', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed', 'description': 'E/A ratio (TEE measurement)'}, {'measure': 'Sus-hepatic vein Doppler profile', 'timeFrame': 'at the begining of cardiac surgery', 'description': 'Sus-hepatic vein Doppler profile (TEE measurement)'}, {'measure': 'Sus-hepatic vein Doppler profile', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.', 'description': 'Sus-hepatic vein Doppler profile (TEE measurement)'}, {'measure': 'Sus-hepatic vein Doppler profile', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed', 'description': 'Sus-hepatic vein Doppler profile (TEE measurement)'}, {'measure': 'Invasive arterial pressure (mmHg)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Invasive arterial pressure (mmHg)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Invasive arterial pressure (mmHg)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Heart rate (pulse/min)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Heart rate (pulse/min)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Heart rate (pulse/min)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Expired CO2 (mmHg)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Expired CO2 (mmHg)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Expired CO2 (mmHg)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Central venous pressure (mmHg)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Central venous pressure (mmHg)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Central venous pressure (mmHg)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Pulse pressure variation (%)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Pulse pressure variation (%)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Pulse pressure variation (%)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Perfusion index (pulsoxymeter)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Perfusion index (pulsoxymeter)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Perfusion index (pulsoxymeter)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Stroke volume (ml) (Flotrac measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Stroke volume (ml) (Flotrac measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Stroke volume (ml) (Flotrac measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Stroke volume variation (%) (Flotrac measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Stroke volume variation (%) (Flotrac measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Stroke volume variation (%) (Flotrac measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Cardiac index (l/min/m2) (Flotrac measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Cardiac index (l/min/m2) (Flotrac measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Cardiac index (l/min/m2) (Flotrac measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Pulse pressure variation (%) (Flotrac measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Pulse pressure variation (%) (Flotrac measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Pulse pressure variation (%) (Flotrac measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Arterial pressure (mmHg) (Flotrac measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Arterial pressure (mmHg) (Flotrac measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Arterial pressure (mmHg) (Flotrac measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Stroke volume (ml) (Clearsight measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Stroke volume (ml) (Clearsight measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Stroke volume (ml) (Clearsight measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Stroke volume variation (%) (Clearsight measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Stroke volume variation (%) (Clearsight measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Stroke volume variation (%) (Clearsight measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Cardiac index (l/min/m2) (Clearsight measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Cardiac index (l/min/m2) (Clearsight measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Cardiac index (l/min/m2) (Clearsight measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Pulse pressure variation (%) (Clearsight measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Pulse pressure variation (%) (Clearsight measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Pulse pressure variation (%) (Clearsight measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Arterial pressure (mmHg) (Clearsight measurement)', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Arterial pressure (mmHg) (Clearsight measurement)', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Arterial pressure (mmHg) (Clearsight measurement)', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}, {'measure': 'Near infrared spectroscopy : Cerebral SrO2', 'timeFrame': 'at the begining of cardiac surgery'}, {'measure': 'Near infrared spectroscopy : Cerebral SrO2', 'timeFrame': 'After fluid challenges until patient is on a preload independency state.'}, {'measure': 'Near infrared spectroscopy : Cerebral SrO2', 'timeFrame': 'After the cardiopulmonary bypass period, when sternotomy will be closed'}]}, 'conditionsModule': {'keywords': ['Alveolar recruitment manoeuvre', 'Lung recruitment', 'Preload dependency', 'Cardiac surgery', 'Transoesophageal echocardiography'], 'conditions': ['Coronary Artery Disease', 'Coronary Artery Bypass', 'Hypovolemia', 'Anesthesia, General', 'Pulmonary Atelectasis']}, 'descriptionModule': {'briefSummary': 'The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.', 'detailedDescription': 'Population studied: anesthetized patients for cardiac surgery of coronary bypass.\n\nSecondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)\n\n\\- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected\n\nExclusion Criteria:\n\n* Emergency case\n* Pericardial effusion\n* Aortic or mitral valvulopathy\n* Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion\n* Bad echogenicity\n* Patient refusal to participate to the study\n* No health insurance'}, 'identificationModule': {'nctId': 'NCT02678559', 'acronym': 'PreDeARM', 'briefTitle': 'Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres', 'orgStudyIdInfo': {'id': 'CHU-0254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEE monitory system', 'description': 'comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.', 'interventionNames': ['Other: tee measurement', 'Other: flotrac measurement', 'Other: clearsight measurement']}, {'type': 'EXPERIMENTAL', 'label': 'mini-invasive monitoring system', 'description': 'comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.', 'interventionNames': ['Other: tee measurement', 'Other: flotrac measurement', 'Other: clearsight measurement']}], 'interventions': [{'name': 'tee measurement', 'type': 'OTHER', 'armGroupLabels': ['TEE monitory system', 'mini-invasive monitoring system']}, {'name': 'flotrac measurement', 'type': 'OTHER', 'armGroupLabels': ['TEE monitory system', 'mini-invasive monitoring system']}, {'name': 'clearsight measurement', 'type': 'OTHER', 'armGroupLabels': ['TEE monitory system', 'mini-invasive monitoring system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}