Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT03447366
Status:
UNKNOWN
Last Update Posted:
2021-09-22
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of the occuring of premature degradation respiratory', 'timeFrame': '30 minutes after vascular filling', 'description': 'definied by a reduction of at least 15% of the SpO2/FiO2 ratio in the 30min following the vascular filling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiration, Artificial', 'Vascular Filling', 'Echocardiography']}, 'descriptionModule': {'briefSummary': 'Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.', 'detailedDescription': 'Mitral Doppler will be performed before vascular filling. Patients will be classified in two groups (normal or high cardiac filling pressure).\n\nThe evolution of the respiratory data (SpO2/FiO2) of the two groups of the patients before and after vascular filling will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical ventilation\n* And hemodynamic failure\n* And decision of the attending physician to perform a vascular filling\n\nExclusion Criteria:\n\n* Pregnancy and breast-feeding women\n* Patients deprived of their administrative or judicial freedom'}, 'identificationModule': {'nctId': 'NCT03447366', 'acronym': 'EVALDM', 'briefTitle': 'Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Metropole Savoie'}, 'officialTitle': 'Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study', 'orgStudyIdInfo': {'id': 'CHMS17002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitral doppler', 'description': 'Mitral doppler before and after vascular filling', 'interventionNames': ['Diagnostic Test: mitral doppler']}], 'interventions': [{'name': 'mitral doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Mitral doppler before and after vascular filling', 'armGroupLabels': ['Mitral doppler']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bourg-en-Bresse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicholas Sedillot', 'role': 'CONTACT'}, {'name': 'Camille Bouisse', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-Baptiste Palluy', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yves Poncelin de Raucourt', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adrien Robine', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier Tchenio', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicholas SEDILLOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ch Bourg En Bresse', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '73000', 'city': 'Chambéry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent Peigne', 'role': 'CONTACT', 'email': 'vincent.peigne@ch-metropole-savoie.fr', 'phone': '04.79.96.61.52'}, {'name': 'Jean-Marc Thouret', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bénédicte Zerr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vincent Susset', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michel Badet', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yvonnick Boue', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Bouard', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catherine Chastagner', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien Lavolaine', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mattéo Miquet', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Sauvajon', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agnès Vinay', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stéphane Combaz', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Clémence Fauche', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vincent Peigne', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Metropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Terzi Nicolas', 'role': 'CONTACT'}, {'name': 'Carole Schwebel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas Terzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}], 'centralContacts': [{'name': 'Vincent Peigne', 'role': 'CONTACT', 'email': 'vincent.peigne@ch-metropole-savoie.fr', 'phone': '0479966152', 'phoneExt': '33'}, {'name': 'Bénédicte Zerr', 'role': 'CONTACT', 'email': 'benedicte.zerr@ch-metropole-savoie.fr', 'phone': '0479966152', 'phoneExt': '33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Metropole Savoie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}