Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02652858
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of femoral, radial and humeral pulses during a cardiopulmonary by-pass (CPBP).', 'timeFrame': 'Day one (6 times)', 'description': "Pulse wave's speed is calculated using 1) time between ECG R-wave and local detection of the pulse wave (femoral, humeral and radial) 2) a length from heart to these sites.\n\nWave detection at femoral and humeral sites will use oscillometry and wave detection at radial site will use an invasive catheter which is always set for this surgery."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Bypass', 'Cardiac Surgery', 'Extracorporeal Circulation']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'N. Smal, L. Guigue, D. Anglade, C. Lavault, F. Grimbert, Y. Lavault, F. Boucher, J.L. Fellahi. Assessment of central-peripheral arterial pressure decoupling: a preliminary study in cardiac surgery under cardiopulmonary bypass (CPB). Abstract presented at the Annual Congress of the French Society of Anaesthesia and Intensive Care (SFAR), Paris, 2017.'}]}, 'descriptionModule': {'briefSummary': "Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines.\n\nThe aim of this study is to evaluate the pulse wave's speed as a marker of central and peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary bypass during cardiac surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass\n* Cardiopulmonary bypass is at least 90 minutes\n* Written consent is needed\n\nExclusion Criteria:\n\n* Patient with heart rate disorder\n* Patient with aortic dissection\n* Dobutamine/milrinone/levosimendan treatment before surgery\n* Patient with heart rate due to a pacemaker'}, 'identificationModule': {'nctId': 'NCT02652858', 'acronym': 'CAPD-CPB', 'briefTitle': 'Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass', 'orgStudyIdInfo': {'id': '69HCL15_0400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Pulse wave's speed observational arm", 'description': "Whole patients for who the pulse wave's speed are measured during a cardiopulmonary bypass during cardiac surgery", 'interventionNames': ['Procedure: Non-invasive blood pressure oscillometer (NIBP) implementation']}], 'interventions': [{'name': 'Non-invasive blood pressure oscillometer (NIBP) implementation', 'type': 'PROCEDURE', 'description': 'Implementation of two additional NIBP on humeral and femoral sites.', 'armGroupLabels': ["Pulse wave's speed observational arm"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Joseph Fournier Grenoble 1', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}