Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-22 @ 10:29 AM
Study NCT ID:
NCT02887560
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantation', 'timeFrame': 'Outcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.'}, {'measure': 'Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantation', 'timeFrame': 'utcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Right ventricle', 'Pulmonary transplantation', 'Strain', 'isovolumic acceleration (IVA)'], 'conditions': ['Primary Lung Graft Dysfunction']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.\n\nSecondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (over 18 years)\n* Patient affiliated to a social protection scheme insurance\n* Patient was informed of the study and w gave their consent\n* Patient on the lung transplant list\n* Patient eligible for a pulmonary transplantation after decision of a multidisciplinary team\n* Patients with chronic lung disease with parenchymal dysfunctions (Chronic obstructive pulmonary disease or COPD, alpha-1 antitrypsin deficiency, cystic fibrosis, pulmonary fibrosis, bronchiolitis obliterans organizing pneumonia or BOOP)\n\nExclusion Criteria:d\n\n* Minor patients\n* Patient under judicial protection, under guardianship\n* Patient in exclusion period (determined by a previous study or in progress)\n* Patient participating in parallel in another clinical trial that may interfere with the results of the study\n* Inability to give informed patient information (emergency, understanding difficulties, etc ...)\n* The refusal of patient consent\n* The use of cardiopulmonary bypass during lung transplantation\n* Uni-pulmonary transplant\n* A transplant for idiopathic or primary pulmonary hypertension\n* The presence of a cons-indication for transesophageal echocardiography:\n\n o Absolute contraindications:\n* Abnormalities of the esophagus: stenosis, tumor, diverticulum perforation, active bleeding\n\n o Relative contraindications:\n* ancient cervicothoracic irradiation history (\\> 10 years)\n* recent upper gastrointestinal bleeding history\n* presence of esophageal varices ≥ grade II\n* zero cervical mobility\n* Reflux Esophagitis\n* Severe coagulation disorders\n* Pregnancy / Breastfeeding'}, 'identificationModule': {'nctId': 'NCT02887560', 'acronym': 'ETO VD PERIOP', 'briefTitle': 'Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.', 'orgStudyIdInfo': {'id': '6283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patient', 'description': 'Only one arm has been specified for the protocol. This arm included all study patient (33) for which the intervention is to be administered', 'interventionNames': ['Procedure: transoesophageal echocardiography']}], 'interventions': [{'name': 'transoesophageal echocardiography', 'type': 'PROCEDURE', 'armGroupLabels': ['All patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Strasbourg's New Civil Hospital, Cardiac surgical reanimation department", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Gharib Ajob, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Strasbourg's University Hospitals"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}