Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-04-19 @ 5:56 AM
Study NCT ID:
NCT02138903
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-28', 'studyFirstSubmitDate': '2014-04-11', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular filling pressure', 'timeFrame': 'after 1 hour', 'description': 'Echo-cardiographic evaluation is realized at the end of the weaning trial (1 hour) or less if failed'}], 'secondaryOutcomes': [{'measure': 'Comparison of other echocardiographic parameters of left ventricular filling pressures', 'timeFrame': 'after 1 hour', 'description': 'Comparison of other echocardiographic parameters of left ventricular filling pressures (E, Ea, deceleration time) at the end of weaning trial'}]}, 'conditionsModule': {'keywords': ['weaning', 'Cardiac', 'Echocardiography', 'Mechanical Ventilation'], 'conditions': ['Critical Care', 'Weaning of Mechanical Ventilation', 'Trans-thoracic Echocardiography', 'Mitral Doppler', 'Diastolic Function']}, 'descriptionModule': {'briefSummary': 'Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.', 'detailedDescription': 'Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ventilated requiring first weaning trial of mechanical ventilation\n\n * Stable respiratory and hemodynamic conditions\n * Consent of patients or family\n * Arterial line\n * Ventilated patients\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02138903', 'acronym': 'CARWEAN', 'briefTitle': 'A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial', 'orgStudyIdInfo': {'id': 'CHU-189'}, 'secondaryIdInfos': [{'id': '2013-000960-26'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ZEEP and tubing-spontaneous ventilation', 'description': 'Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.', 'interventionNames': ['Other: trans thoracic echocardiography']}, {'label': 'trans-thoracic echocardiography', 'description': 'Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.', 'interventionNames': ['Other: trans thoracic echocardiography']}], 'interventions': [{'name': 'trans thoracic echocardiography', 'type': 'OTHER', 'armGroupLabels': ['ZEEP and tubing-spontaneous ventilation', 'trans-thoracic echocardiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Sébastien PERBET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}