Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-13 @ 1:31 PM
Study NCT ID:
NCT02812758
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS)', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients that change their preload dependence status during a change in sedation depth (as evaluated by the BIS).', 'timeFrame': 'Day 0'}]}, 'conditionsModule': {'keywords': ['sedation depth', 'indices of preload dependence'], 'conditions': ['Thoracic Surgery']}, 'descriptionModule': {'briefSummary': 'Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. However, the influence of the sedation depth on these dynamic indices has never been evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)\n* Good echogenicity\n* Social security coverage\n\nExclusion Criteria:\n\n* Pregnancy, legal guardianship\n* Subjects with black skin (a known technical limitation of plethysmography)\n* Cardiac arrhythmia\n* Sepsis\n* Poor echogenicity'}, 'identificationModule': {'nctId': 'NCT02812758', 'acronym': 'BIS2', 'briefTitle': 'Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study', 'orgStudyIdInfo': {'id': 'PI2015_843_0012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients', 'description': 'All sedated, intubated, mechanically ventilated adult patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI) transthoracic echocardiography', 'interventionNames': ['Device: transthoracic echocardiography']}], 'interventions': [{'name': 'transthoracic echocardiography', 'type': 'DEVICE', 'description': 'recording of data on cardiac output measured non-invasively by transthoracic echocardiography, including the SVV', 'armGroupLabels': ['patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Emmanuel LORNE, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}