Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
Study NCT ID:
NCT02717468
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2016-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002302', 'term': 'Cardiac Output'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Ejection Volume (SEV) measure by ClearSight®', 'timeFrame': '24 hours'}, {'measure': 'Stroke Ejection Volume (SEV) measure by Pulsioflex®', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Cardiac Output (CO) measure by ClearSight®', 'timeFrame': '24 hours'}, {'measure': 'Cardiac Output (CO) measure by Pulsioflex®', 'timeFrame': '24 hours'}, {'measure': 'Stroke Ejection Volume Variations (SVV) measure by ClearSight®', 'timeFrame': '24 hours'}, {'measure': 'Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'conditions': ['Cardiac Output Measurement']}, 'descriptionModule': {'briefSummary': 'In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.\n\nToday, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.\n\nThe future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.\n\nThe objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients scheduled to undergo major surgery\n* Patients monitored by a Pulsioflex® device\n\nExclusion Criteria:\n\n* Patients with heart rhythm disorder\n* Patients with Raynaud's disease or vasculitis\n* Emergency surgery\n* Significant edema fingers"}, 'identificationModule': {'nctId': 'NCT02717468', 'acronym': 'CLEARSIGHT', 'briefTitle': 'Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery', 'orgStudyIdInfo': {'id': '2015-A01895-44'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)', 'type': 'DEVICE'}, {'name': 'Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Matthieu BOISSON', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}